AzTrials
AzTrials

Arthritis, RheumatoidPhase 3contRAst XNCT04333147

Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)

A Phase 3 study testing Otilimab (GSK3196165) and csDMARD(s) in people with Arthritis, Rheumatoid, run by GlaxoSmithKline at 375 sites in 27 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

RA is a chronic, systemic inflammatory autoimmune disease which requires treatment for a long time period, hence it is important to study the long-term safety and efficacy of the continuous treatment with GSK3196165 over several years. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arthritis, Rheumatoid
What is being tested?
Otilimab (GSK3196165) and csDMARD(s)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,916 participants
Where
375 sitesin 27 countries
Study dates
12 May 2020to 24 Feb 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants with rheumatoid arthritis who are aged >=18 years at the time of signing informed consent, who have completed one of the qualifying GSK3196165 clinical studies and who, in the opinion of the investigator, may benefit from treatment with GSK3196165.
  • Body weight >=40 kilograms (kg).
  • Male or female participants are eligible to participate as long as they meet the contraceptive eligibility criteria and agree to abide by the contraceptive requirements.
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  • For participants on methotrexate (MTX): must be willing to continue treatment with oral folic acid (at least 5 mg/week) or equivalent while receiving MTX (mandatory co-medication for MTX treatment).

Who cannot join

  • Had study intervention permanently discontinued at any time during a qualifying study except any participant with a new diagnosis of latent Mycobacterium tuberculosis (TB) at the end of study assessment in a qualifying study and currently undertaking or willing to complete at least 4 weeks of anti-TB treatment off study treatment, per world health organization (WHO) or national guidelines prior to re-commencing therapy and complete the remainder of anti-TB treatment while on study.
  • Evidence of latent TB (as documented by a positive QuantiFERON-TB Gold plus test or T-SPOT.TB test, no findings on medical history or clinical examination consistent with active TB, and a normal chest radiograph) except for participants that
  • Are currently undertaking or willing to complete at least 4 weeks of anti-TB therapy off study treatment, as per WHO or national guidelines prior to re- commencing study treatment and agree to complete the remainder of anti-TB treatment while in the study or
  • Had documented evidence of satisfactory anti-TB treatment as per WHO or national guidelines following review by a physician specializing in TB on entry to a qualifying study.
  • Current or previous active TB regardless of treatment.
  • Were temporarily discontinued from study intervention at the time of the final study visit of a qualifying study and, in the opinion of the investigator, participation in the extension study poses an unacceptable risk for the participant's participation.
Show all 14Show fewer
  • A new cancer or malignancy except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix treated and considered cured by the investigator.
  • Have developed any lymphoproliferative disorder during a qualifying study, such as Epstein Barr Virus (EBV) related lymphoproliferative disorder, or signs and symptoms suggestive of current lymphatic disease.
  • Have significant uncontrolled cardiovascular, cerebrovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neuropsychiatric disorders, or abnormal laboratory values that developed during a qualifying study that, in the opinion of the investigator, poses an unacceptable risk for the participant's participation.
  • Participants who are expected to be non-compliant with restrictions on medications and vaccinations prior to the study, during the study or during the 8-week safety follow-up of the study.
  • Participants who are currently participating in any interventional clinical study other than a qualifying GSK3196165 clinical study.
  • Abnormal chest radiograph within the last 12 weeks judged by the investigator as clinically-significant.
  • Pregnant or lactating, or women planning to become pregnant or initiating breastfeeding.
  • History of sensitivity to any of the study treatments, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.

Trial locations and contacts

375 sites in 27 countries.

375 sites in 27 countries

United States79 sites

  • GSK Investigational Site

    Amarillo, Texas, 79124

  • GSK Investigational Site

    Anniston, Alabama, 36207

  • GSK Investigational Site

    Atlanta, Georgia, 30318

  • GSK Investigational Site

    Austin, Texas, 78731

  • GSK Investigational Site

    Austin, Texas, 78745

  • GSK Investigational Site

    Aventura, Florida, 33180

  • GSK Investigational Site

    Baytown, Texas, 77521

  • GSK Investigational Site

    Bowling Green, Kentucky, 42101

  • GSK Investigational Site

    Brandon, Florida, 33511

  • GSK Investigational Site

    Brooklyn, New York, 11201

  • GSK Investigational Site

    Cincinnati, Ohio, 45242

  • GSK Investigational Site

    Clearwater, Florida, 33765

  • GSK Investigational Site

    Colleyville, Texas, 76034

  • GSK Investigational Site

    Covina, California, 91722

  • GSK Investigational Site

    Dallas, Texas, 75231

  • GSK Investigational Site

    Daytona Beach, Florida, 32117

  • GSK Investigational Site

    Denver, Colorado, 80230

  • GSK Investigational Site

    Evansville, Indiana, 47715

  • GSK Investigational Site

    Fayetteville, North Carolina, 30214

  • GSK Investigational Site

    Flagstaff, Arizona, 86001

  • GSK Investigational Site

    Fort Collins, Colorado, 80528

  • GSK Investigational Site

    Freehold, New Jersey, 07728

  • GSK Investigational Site

    Gilbert, Arizona, 85297

  • GSK Investigational Site

    Glendale, Arizona, 85306

  • GSK Investigational Site

    Glendale, Wisconsin, 53217

  • GSK Investigational Site

    Grand Blanc, Michigan, 48439

  • GSK Investigational Site

    Greensboro, North Carolina, 27408

  • GSK Investigational Site

    Greenville, South Carolina, 29601

  • GSK Investigational Site

    Houston, Texas, 77065

  • GSK Investigational Site

    Houston, Texas, 77084

  • GSK Investigational Site

    Houston, Texas, 77089

  • GSK Investigational Site

    Houston, Texas, 77090

  • GSK Investigational Site

    Idaho Falls, Idaho, 83404

  • GSK Investigational Site

    Jacksonville, Florida, 32207

  • GSK Investigational Site

    Lake Charles, Louisiana, 70601

  • GSK Investigational Site

    Lansing, Michigan, 48910

  • GSK Investigational Site

    Lebanon, New Hampshire, 03756

  • GSK Investigational Site

    Lincoln, Nebraska, 68516

  • GSK Investigational Site

    Lubbock, Texas, 79410

  • GSK Investigational Site

    Marietta, Georgia, 30060

  • GSK Investigational Site

    Mesa, Arizona, 85210

  • GSK Investigational Site

    Miami, Florida, 33134

  • GSK Investigational Site

    Miami, Florida, 33155

  • GSK Investigational Site

    Miami, Florida, 33165

  • GSK Investigational Site

    Miami, Florida, 33173

  • GSK Investigational Site

    Miami Lakes, Florida, 33014

  • GSK Investigational Site

    Miami Lakes, Florida, 33016

  • GSK Investigational Site

    Minot, North Dakota, 58701

  • GSK Investigational Site

    Monroe, Louisiana, 71203

  • GSK Investigational Site

    New Port Richey, Florida, 34652

  • GSK Investigational Site

    Novi, Michigan, 48375

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73103

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73104

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73112

  • GSK Investigational Site

    Orlando, Florida, 32835

  • GSK Investigational Site

    Palmetto Bay, Florida, 33157

  • GSK Investigational Site

    Phoenix, Arizona, 85032

  • GSK Investigational Site

    Phoenix, Arizona, 85037

  • GSK Investigational Site

    Plano, Texas, 75024

  • GSK Investigational Site

    Poway, California, 92064

  • GSK Investigational Site

    San Diego, California, 92108

  • GSK Investigational Site

    San Diego, California, 92128

  • GSK Investigational Site

    Skokie, Illinois, 60076

  • GSK Investigational Site

    St Louis, Missouri, 63141

  • GSK Investigational Site

    Summerville, South Carolina, 29486

  • GSK Investigational Site

    Tamarac, Florida, 33321

  • GSK Investigational Site

    Tampa, Florida, 33603

  • GSK Investigational Site

    Tampa, Florida, 33614

  • GSK Investigational Site

    The Woodlands, Texas, 77382

  • GSK Investigational Site

    Tomball, Texas, 77375

  • GSK Investigational Site

    Tucson, Arizona, 85704

  • GSK Investigational Site

    Upland, California, 91786

  • GSK Investigational Site

    Van Nuys, California, 91405

  • GSK Investigational Site

    Vandalia, Ohio, 45377

  • GSK Investigational Site

    Waco, Texas, 76710

  • GSK Investigational Site

    Wheaton, Maryland, 20902

  • GSK Investigational Site

    Whittier, California, 90602

  • GSK Investigational Site

    Wichita, Kansas, 67207

  • GSK Investigational Site

    Yukon, Oklahoma, 73099

Other trials in United States

Japan48 sites

  • GSK Investigational Site

    Aichi, 455-8530

  • GSK Investigational Site

    Aichi, 457-8511

  • GSK Investigational Site

    Aichi, 466-8560

  • GSK Investigational Site

    Chiba, 260-8712

  • GSK Investigational Site

    Chiba, 270-2296

  • GSK Investigational Site

    Chiba, 284-0003

  • GSK Investigational Site

    Fukuoka, 804-0025

  • GSK Investigational Site

    Fukuoka, 807-8555

  • GSK Investigational Site

    Fukuoka, 814-0180

  • GSK Investigational Site

    Fukuoka, 820-8505

  • GSK Investigational Site

    Hiroshima, 734-8551

  • GSK Investigational Site

    Hokkaido, 053-8567

  • GSK Investigational Site

    Hokkaido, 060-0001

  • GSK Investigational Site

    Hokkaido, 060-8648

  • GSK Investigational Site

    Hokkaido, 063-0811

  • GSK Investigational Site

    Hokkaido, 085-0032

  • GSK Investigational Site

    Hyōgo, 673-1462

  • GSK Investigational Site

    Hyōgo, 675-1392

  • GSK Investigational Site

    Ibaraki, 312-0057

  • GSK Investigational Site

    Kagawa, 761-0793

  • GSK Investigational Site

    Kagoshima, 891-0133

  • GSK Investigational Site

    Kanagawa, 231-8682

  • GSK Investigational Site

    Kanagawa, 232-0024

  • GSK Investigational Site

    Kanagawa, 245-8575

  • GSK Investigational Site

    Kanagawa, 252-0392

  • GSK Investigational Site

    Kochi, 780-8522

  • GSK Investigational Site

    Kochi, 781-0112

  • GSK Investigational Site

    Kumamoto, 862-0975

  • GSK Investigational Site

    Miyagi, 980-8574

  • GSK Investigational Site

    Miyagi, 983-8512

  • GSK Investigational Site

    Nagano, 380-8582

  • GSK Investigational Site

    Nagasaki, 850-0832

  • GSK Investigational Site

    Nagasaki, 852-8501

  • GSK Investigational Site

    Nagasaki, 857-1195

  • GSK Investigational Site

    Niigata, 940-2085

  • GSK Investigational Site

    Niigata, 957-0054

  • GSK Investigational Site

    Okayama, 700-0013

  • GSK Investigational Site

    Okayama, 700-8557

  • GSK Investigational Site

    Okayama, 700-8607

  • GSK Investigational Site

    Saitama, 359-1111

  • GSK Investigational Site

    Tokyo, 104-8560

  • GSK Investigational Site

    Tokyo, 113-8431

  • GSK Investigational Site

    Tokyo, 113-8519

  • GSK Investigational Site

    Tokyo, 142-8666

  • GSK Investigational Site

    Tokyo, 153-8515

  • GSK Investigational Site

    Tokyo, 198-0042

  • GSK Investigational Site

    Wakayama, 649-2211

  • GSK Investigational Site

    Yamaguchi, 750-8520

Other trials in Japan

Poland38 sites

  • GSK Investigational Site

    Bialystok, 15-351

  • GSK Investigational Site

    Bialystok, 15-879

  • GSK Investigational Site

    Bydgoszcz, 85-065

  • GSK Investigational Site

    Bydgoszcz, 85-168

  • GSK Investigational Site

    Częstochowa, 42202

  • GSK Investigational Site

    Elblag, 82-300

  • GSK Investigational Site

    Gdansk, 80-382

  • GSK Investigational Site

    Gdynia, 81-338

  • GSK Investigational Site

    Gdynia, 81-537

  • GSK Investigational Site

    Grodzisk Mazowiecki, 05-825

  • GSK Investigational Site

    Katowice, 40-040

  • GSK Investigational Site

    Katowice, 40-282

  • GSK Investigational Site

    Krakow, 30-033

  • GSK Investigational Site

    Krakow, 30-363

  • GSK Investigational Site

    Krakow, 30-510

  • GSK Investigational Site

    Lodz, 90-127

  • GSK Investigational Site

    Lodz, 90-644

  • GSK Investigational Site

    Lublin, 20-362

  • GSK Investigational Site

    Lublin, 20-582

  • GSK Investigational Site

    Nowa Sól, 67-100

  • GSK Investigational Site

    Olsztyn, 10-117

  • GSK Investigational Site

    Poznan, 60-529

  • GSK Investigational Site

    Poznan, 60-702

  • GSK Investigational Site

    Poznan, 60-773

  • GSK Investigational Site

    Poznan, 61-113

  • GSK Investigational Site

    Siedlce, 08-110

  • GSK Investigational Site

    Sochaczew, 96-500

  • GSK Investigational Site

    Staszów, 28-200

  • GSK Investigational Site

    Torun, 87-100

  • GSK Investigational Site

    Warsaw, 00-465

  • GSK Investigational Site

    Warsaw, 00-874

  • GSK Investigational Site

    Warsaw, 01-192

  • GSK Investigational Site

    Warsaw, 02-118

  • GSK Investigational Site

    Warsaw, 02-673

  • GSK Investigational Site

    Warsaw, 02-793

  • GSK Investigational Site

    Wroclaw, 50-381

  • GSK Investigational Site

    Wroclaw, 52-416

  • GSK Investigational Site

    Zamość, 22-400

Other trials in Poland

China25 sites

  • GSK Investigational Site

    Baotou, Inner Mongolia, 014010

  • GSK Investigational Site

    Beijing, 100015

  • GSK Investigational Site

    Beijing, 100144

  • GSK Investigational Site

    Bengbu, Anhui, 233004

  • GSK Investigational Site

    Changchun, Jilin, 130021

  • GSK Investigational Site

    Changsha, Hunan, 410013

  • GSK Investigational Site

    Chengdu, Sichuan, 610041

  • GSK Investigational Site

    Guangzhou, 510080

  • GSK Investigational Site

    Guilin, Guangxi, 541001

  • GSK Investigational Site

    Hangzhou, 310005

  • GSK Investigational Site

    Huzhou, Zhejiang, 313000

  • GSK Investigational Site

    Jinzhou, Liaoning, 121000

  • GSK Investigational Site

    Nanchang, Jiangxi, 330006

  • GSK Investigational Site

    Nanjing, 210008

  • GSK Investigational Site

    Pingxiang, Jiangxi, 337055

  • GSK Investigational Site

    Shanghai, 200040

  • GSK Investigational Site

    Shijiazhuang, Hebei, 050051

  • GSK Investigational Site

    Taizhou, Jiangsu, 225300

  • GSK Investigational Site

    Tianjin, 300052

  • GSK Investigational Site

    Tongliao, Inner Mongolia, 10050

  • GSK Investigational Site

    Wuhan, Hubei, 430030

  • GSK Investigational Site

    Xuzhou, Jiangsu, 221009

  • GSK Investigational Site

    Yangzhou, 225000

  • GSK Investigational Site

    Yanji, 133000

  • GSK Investigational Site

    Zhuzhou, Hunan, 412007

Other trials in China

Argentina23 sites

  • GSK Investigational Site

    Buenos Aires, C1426BOR

  • GSK Investigational Site

    Buenos Aires, C1430CKE

  • GSK Investigational Site

    Ciudad Autonoma Buenos Aires, Buenos Aires, C1046AAQ

  • GSK Investigational Site

    Ciudad Autonoma Buenos Aires, Buenos Aires, C1114ABH

  • GSK Investigational Site

    Ciudad Autonoma Buenos Aires, Buenos Aires, C1417

  • GSK Investigational Site

    Ciudad Autonoma Buenos Aires, Buenos Aires, C1430EGF

  • GSK Investigational Site

    Ciudad Autonoma Buenos Aires, C1015ABO

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, 1426

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1128AAF

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1431FWO

  • GSK Investigational Site

    Córdoba, Córdoba Province, X5003DCE

  • GSK Investigational Site

    Córdoba, 5000

  • GSK Investigational Site

    La Palta, Buenos Aires, B1900AXI

  • GSK Investigational Site

    Mar del Plata, Buenos Aires, B7600FYK

  • GSK Investigational Site

    Nueva Cordoba, X5000AVE

  • GSK Investigational Site

    Quilmes, Buenos Aires, B1878GEG

  • GSK Investigational Site

    Rosario, Santa Fe Province, S2000DSV

  • GSK Investigational Site

    Salta, A4400ANW

  • GSK Investigational Site

    San Isidro, Buenos Aires, 1643

  • GSK Investigational Site

    San Juan, 5400

  • GSK Investigational Site

    San Miguel de Tucumán, Tucumán Province, T4000AXL

  • GSK Investigational Site

    San Miguel de Tucumán, Tucumán Province, T4000BRD

  • GSK Investigational Site

    San Nicolás de los Arroyos, Buenos Aires, B2900DMH

Other trials in Argentina

Russia22 sites

  • GSK Investigational Site

    Kemerovo, 650066

  • GSK Investigational Site

    Kemerovo, 650070

  • GSK Investigational Site

    Korolyov, 141060

  • GSK Investigational Site

    Krasnoyarsk, 660022

  • GSK Investigational Site

    Moscow, 115404

  • GSK Investigational Site

    Moscow, 115522

  • GSK Investigational Site

    Moscow, 129110

  • GSK Investigational Site

    Novosibirsk, 630091

  • GSK Investigational Site

    Novosibirsk, 630099

  • GSK Investigational Site

    Omsk, 644024

  • GSK Investigational Site

    Saint Petersburg, 190068

  • GSK Investigational Site

    Saint Petersburg, 197022

  • GSK Investigational Site

    Saratov, 410012

  • GSK Investigational Site

    Smolensk, 214025

  • GSK Investigational Site

    Tomsk, 634061

  • GSK Investigational Site

    Tver', 170036

  • GSK Investigational Site

    Ulyanovsk, 432063

  • GSK Investigational Site

    Yaroslavl, 150003

  • GSK Investigational Site

    Yaroslavl, 150007

  • GSK Investigational Site

    Yaroslavl, 150062

  • GSK Investigational Site

    Yekaterinburg, 620043

  • GSK Investigational Site

    Yekaterinburg, 620102

Other trials in Russia

Ukraine22 sites

  • GSK Investigational Site

    Cherkasy, 18009

  • GSK Investigational Site

    Ivano-Frankivsk, 76008

  • GSK Investigational Site

    Kharkiv, 61039

  • GSK Investigational Site

    Kharkiv, 61124

  • GSK Investigational Site

    Kharkiv, 61176

  • GSK Investigational Site

    Kyiv, 02125

  • GSK Investigational Site

    Kyiv, 03037

  • GSK Investigational Site

    Kyiv, 03049

  • GSK Investigational Site

    Kyiv, 04054

  • GSK Investigational Site

    Kyiv, 1023

  • GSK Investigational Site

    Kyiv, 2002

  • GSK Investigational Site

    Lutsk, 43005

  • GSK Investigational Site

    Lutsk, 43024

  • GSK Investigational Site

    Odesa, 65025

  • GSK Investigational Site

    Poltava, 36011

  • GSK Investigational Site

    Vinnytsia, 21001

  • GSK Investigational Site

    Vinnytsia, 21018

  • GSK Investigational Site

    Vinnytsia, 21029

  • GSK Investigational Site

    Vinnytsia, 21050

  • GSK Investigational Site

    Zaporizhzhya, 69014

  • GSK Investigational Site

    Zaporizhzia, 69065

  • GSK Investigational Site

    Zhytomyr, 10002

Other trials in Ukraine

India13 sites

  • GSK Investigational Site

    Ahmedabad, 380005

  • GSK Investigational Site

    Ahmedabad, 380016

  • GSK Investigational Site

    Belagavi, 590010

  • GSK Investigational Site

    Hubli, 580021

  • GSK Investigational Site

    Hyderabad, 500018

  • GSK Investigational Site

    Jaipur, 302001

  • GSK Investigational Site

    Jaipur, 302006

  • GSK Investigational Site

    Kolkata, 700020

  • GSK Investigational Site

    Nagpur, 440009

  • GSK Investigational Site

    Nagpur, 440012

  • GSK Investigational Site

    New Delhi, 110026

  • GSK Investigational Site

    Pune, 411004

  • GSK Investigational Site

    Surat, 395002

Other trials in India

South Africa12 sites

  • GSK Investigational Site

    Bellville, 7530

  • GSK Investigational Site

    Bloemfontein, 9301

  • GSK Investigational Site

    Cape Town, 7405

  • GSK Investigational Site

    Cape Town, 7500

  • GSK Investigational Site

    Durban, KwaZulu-Natal, 4319

  • GSK Investigational Site

    Johannesburg, 2113

  • GSK Investigational Site

    Johannesburg, 2193

  • GSK Investigational Site

    Kempton Park, 1619

  • GSK Investigational Site

    Pretoria, Gauteng, 184

  • GSK Investigational Site

    Pretoria, 0002

  • GSK Investigational Site

    Somerset West, 7130

  • GSK Investigational Site

    Stellenbosch, 7600

Other trials in South Africa

Czechia11 sites

  • GSK Investigational Site

    Brno, 638 00

  • GSK Investigational Site

    Brno, 65691

  • GSK Investigational Site

    Ostrava, 70200

  • GSK Investigational Site

    Prague, 10000

  • GSK Investigational Site

    Prague, 12850

  • GSK Investigational Site

    Prague, 140 00

  • GSK Investigational Site

    Prague, 148 00

  • GSK Investigational Site

    Prague, 150 06

  • GSK Investigational Site

    Praha 4 Nusle, 140 00

  • GSK Investigational Site

    Uherské Hradiště, 686 01

  • GSK Investigational Site

    Zlín, 760 01

Other trials in Czechia

South Korea11 sites

  • GSK Investigational Site

    Anyang-si, 431-070

  • GSK Investigational Site

    Cheonan-si, 31151

  • GSK Investigational Site

    Daegu, 41944

  • GSK Investigational Site

    Gwangju, 61469

  • GSK Investigational Site

    Incheon, 22332

  • GSK Investigational Site

    Seongnam-si, 13620

  • GSK Investigational Site

    Seoul, 03722

  • GSK Investigational Site

    Seoul, 05505

  • GSK Investigational Site

    Seoul, 06591

  • GSK Investigational Site

    Seoul, 3080

  • GSK Investigational Site

    Suwon-si, Gyeonggi-do, 16499

Other trials in South Korea

Bulgaria10 sites

  • GSK Investigational Site

    Blagoevgrad, 2700

  • GSK Investigational Site

    Pleven, 5800

  • GSK Investigational Site

    Plovdiv, 4000

  • GSK Investigational Site

    Rousse, 7000

  • GSK Investigational Site

    Sevlievo, 5400

  • GSK Investigational Site

    Sofia, 1431

  • GSK Investigational Site

    Sofia, 1606

  • GSK Investigational Site

    Sofia, 1612

  • GSK Investigational Site

    Sofia, 1784

  • GSK Investigational Site

    Vidin, 3700

Other trials in Bulgaria

Mexico9 sites

  • GSK Investigational Site

    Durango, 34270

  • GSK Investigational Site

    Guadalajara, Jalisco, 44130

  • GSK Investigational Site

    Guadalajara, Jalisco, 44650

  • GSK Investigational Site

    León, Guanajuato, 37000

  • GSK Investigational Site

    Mérida, Yucatán, 97070

  • GSK Investigational Site

    Mexicali, Baja California Sur, 21100

  • GSK Investigational Site

    México, 6700

  • GSK Investigational Site

    Mexico City, Durango, 06700

  • GSK Investigational Site

    San Luis Potosí City, 78213

Other trials in Mexico

Spain9 sites

  • GSK Investigational Site

    A Coruña, 15006

  • GSK Investigational Site

    Barcelona, 08003

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    Córdoba, 140044

  • GSK Investigational Site

    Elche, ?03203

  • GSK Investigational Site

    Santander, 39008

  • GSK Investigational Site

    Santiago de Compostela. La Coruña., 15706

  • GSK Investigational Site

    Seville, 41009

  • GSK Investigational Site

    Valencia, 46010

Other trials in Spain

Hungary7 sites

  • GSK Investigational Site

    Baja, 6500

  • GSK Investigational Site

    Balatonfüred, 8230

  • GSK Investigational Site

    Budapest, 1023

  • GSK Investigational Site

    Budapest, 1036

  • GSK Investigational Site

    Székesfehérvár, 8000

  • GSK Investigational Site

    Szentes, 6600

  • GSK Investigational Site

    Veszprém, 8200

Other trials in Hungary

Estonia6 sites

  • GSK Investigational Site

    Pärnu, 80010

  • GSK Investigational Site

    Tallinn, 10117

  • GSK Investigational Site

    Tallinn, 10128

  • GSK Investigational Site

    Tallinn, 13419

  • GSK Investigational Site

    Tartu, 50106

  • GSK Investigational Site

    Tartu, 50708

Other trials in Estonia

Lithuania5 sites

  • GSK Investigational Site

    Kaunas, LT-45130

  • GSK Investigational Site

    Kaunas, LT-50128

  • GSK Investigational Site

    Klaipėda, LT-92288

  • GSK Investigational Site

    Šiauliai, 76231

  • GSK Investigational Site

    Vilnius, LT-01117

Other trials in Lithuania

Colombia4 sites

  • GSK Investigational Site

    Barranquilla, 110221

  • GSK Investigational Site

    Barranquilla, 80020

  • GSK Investigational Site

    Bogotá, 110221

  • GSK Investigational Site

    Bucaramanga, 680003

Other trials in Colombia

Germany4 sites

  • GSK Investigational Site

    Dresden, Saxony, 01307

  • GSK Investigational Site

    Hamburg, 20095

  • GSK Investigational Site

    Magdeburg, 39120

  • GSK Investigational Site

    Rendsburg, Schleswig-Holstein, 24768

Other trials in Germany

Malaysia4 sites

  • GSK Investigational Site

    Klang, 41200

  • GSK Investigational Site

    Kuala Lumpur, 59100

  • GSK Investigational Site

    Seremban, Negeri Sembilan, 70300

  • GSK Investigational Site

    Sibu, 96000

Other trials in Malaysia

United Kingdom3 sites

  • GSK Investigational Site

    Coventry, CV3 4FJ

  • GSK Investigational Site

    Northwood, Middlesex, HA6 2RN

  • GSK Investigational Site

    Orpington, Kent, BR5 3QG

Other trials in United Kingdom

Australia2 sites

  • GSK Investigational Site

    Gold Coast, Queensland, 4222

  • GSK Investigational Site

    Woodville, South Australia, 5011

Other trials in Australia

Canada2 sites

  • GSK Investigational Site

    Brampton, Ontario, L6T 0G1

  • GSK Investigational Site

    Trois-Rivières, Quebec, G8Z 1Y2

Other trials in Canada

Latvia2 sites

  • GSK Investigational Site

    Adazi, LV2164

  • GSK Investigational Site

    Liepāja, LV-3401

Other trials in Latvia

Thailand2 sites

  • GSK Investigational Site

    Bangkok, 10400

  • GSK Investigational Site

    Rajathevee, 10400

Other trials in Thailand

Belgium1 site

  • GSK Investigational Site

    Mons, 7000

Other trials in Belgium

Serbia1 site

  • GSK Investigational Site

    Belgrade, 11000

Other trials in Serbia

About this study

Official title: A Multi-centre Long-term Extension Study to Assess the Safety and Efficacy of GSK3196165 in the Treatment of Rheumatoid Arthritis

RA is a chronic, systemic inflammatory autoimmune disease which requires treatment for a long time period, hence it is important to study the long-term safety and efficacy of the continuous treatment with GSK3196165 over several years. This is a Phase 3, multicenter, parallel group treatment and long-term extension study primarily to assess safety with efficacy assessment as a secondary objective. Adult participants with RA who have completed the treatment phase of a qualifying GSK3196165 clinical studies (Phase 3 studies contRAst 1 (201790: NCT03980483), contRAst 2 (201791: NCT03970837) and contRAst 3 (202018: NCT04134728) and who, in investigator's judgement will benefit from extended treatment with GSK3196165 will be included in this study (contRAst X [209564: NCT04333147]). Participants will continue to receive the same background conventional synthetic disease modifying anti-rheumatic drug(s) [csDMARD(s)] treatment as they received in their qualifying study. Eligible participants will be enrolled to receive weekly GSK3196165 90 milligrams (mg) or 150 mg by subcutaneous (SC) injection. The anticipated study duration is approximately 4 years which will enable participants to receive treatment with GSK3196165 until it is expected to become commercially available. Approximately 3000 participants from the qualifying studies will participate in this long-term extension study

Being tested
Otilimab (GSK3196165), csDMARD(s)
Keywords
Rheumatoid arthritis, GSK3196165, Otilimab, Long-term safety, Long-term efficacy
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Otilimab (GSK3196165)Biological

    GSK3196165 solution in vial/pre-filled syringe (PFS) and auto injector (AI) to be administered SC.

  • csDMARD(s)Drug

    Stable dose of csDMARD(s) as standard of care (SoC).

Study groups in NCT04333147
Study groupRoleWhat they receive
Otilimab 90 mgExperimentalParticipants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.
Receives: Biological: Otilimab (GSK3196165); Drug: csDMARD(s)
Otilimab 150 mgExperimentalParticipants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
Receives: Biological: Otilimab (GSK3196165); Drug: csDMARD(s)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)

    An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAEs are defined as any untoward medical occurrence that, at any dose: results in death, cause life threatening events which requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability or incapacity and birth defect or congenital anomaly. Protocol defined AESIs were included.

    Measured: Up to approximately 145 Weeks

  2. Change From Baseline in Hematology Parameter of Platelet Count at Week 24

    Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.

    Measured: Baseline (Day 01) and Week 24

  3. Change From Baseline in Hematology Parameter of Platelet Count at Week 48

    Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.

    Measured: Baseline (Day 01) and Week 48

  4. Change From Baseline in Hematology Parameter of Platelet Count at Week 96

    Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.

    Measured: Baseline (Day 01) and Week 96

  5. Change From Baseline in Hematology Parameter of Platelet Count at Week 144

    Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.

    Measured: Baseline (Day 01) and Week 144

  6. Change From Baseline in Hematology Parameter of Hemoglobin at Week 24

    Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin.

    Measured: Baseline (Day 01) and Week 24

  7. Change From Baseline in Hematology Parameter of Hemoglobin at Week 48

    Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin.

    Measured: Baseline (Day 01) and Week 48

  8. Change From Baseline in Hematology Parameter of Hemoglobin at Week 96

    Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin.

    Measured: Baseline (Day 01) and Week 96

  9. Change From Baseline in Hematology Parameter of Hemoglobin at Week 144

    Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin.

    Measured: Baseline (Day 01) and Week 144

  10. Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 24

    Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils.

    Measured: Baseline (Day 01) and Week 24

  11. Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 48

    Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils.

    Measured: Baseline (Day 01) and Week 48

  12. Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 96

    Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils.

    Measured: Baseline (Day 01) and Week 96

  13. Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 144

    Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils.

    Measured: Baseline (Day 01) and Week 144

  14. Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 24

    Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK.

    Measured: Baseline (Day 01) and Week 24

  15. Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 48

    Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK.

    Measured: Baseline (Day 01) and Week 48

  16. Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 96

    Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK.

    Measured: Baseline (Day 01) and Week 96

  17. Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 144

    Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK.

    Measured: Baseline (Day 01) and Week 144

  18. Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 24

    Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides

    Measured: Baseline (Day 01) and Week 24

  19. Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 48

    Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides

    Measured: Baseline (Day 01) and Week 48

  20. Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 96

    Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides

    Measured: Baseline (Day 01) and Week 96

  21. Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 144

    Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides

    Measured: Baseline (Day 01) and Week 144

  22. Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities

    Number of participants with NCI-CTCAE >=Grade 3 hematological/clinical chemistry abnormalities were summarized. Hematological and Clinical chemistry parameters were summarized according to the NCI-CTCAE, version 5.0: Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling. Higher grade indicates more severity. Data is presented for only those parameters for which participants had worst case >=Grade 3 shifts from Baseline.

    Measured: Up to approximately 145 Weeks

  23. Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 24

    Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin.

    Measured: Baseline (Day 01) and Week 24

  24. Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 48

    Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin.

    Measured: Baseline (Day 01) and Week 48

  25. Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 96

    Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin.

    Measured: Baseline (Day 01) and Week 96

  26. Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 144

    Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin.

    Measured: Baseline (Day 01) and Week 144

Secondary outcomes (16)

  1. Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score Lesser Than or Equal to (<=)10 (CDAI) Low Disease Activity (LDA) at Week 24, 48, 96 and 144

    Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low disease activity (LDA) is achieved when CDAI total score <=10. Percentage values are rounded off.

    Measured: Week 24, 48, 96 and 144

  2. Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score <=2.8 (CDAI Remission) at Week 24, 48, 96 and 144

    Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. CDAI remission is achieved when CDAI total score <=2.8. Percentage values are rounded off.

    Measured: Week 24, 48, 96 and 144

  3. Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) <2.6 at Week 24, 48, 96 and 144

    The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). PtGA is transformed to a 0-10 scale before computing the total score. DAS28- CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Low disease activity (LDA) is achieved when DAS28-CRP greater than or equal to (<=)3.2. A negative change from baseline in DAS28-CRP indicates an improvement. Percentage values are rounded off.

    Measured: Week 24, 48, 96 and 144

  4. Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (ESR) <2.6 (DAS28-ESR Remission) at Week 24, 48, 96 and 132

    The DAS28-ESR is a measure of RA disease activity calculated using TJC28,SJC28, ESR (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). PtGA is transformed to a 0-10 scale before computing the total score. DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity. Remission is achieved when DAS28-ESR <2.6. A negative change from baseline in DAS28-ESR indicates an improvement. Percentage values are rounded off.

    Measured: Week 24, 48, 96 and 132

  5. Percentage of Participants Achieving American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission at Week 24, 48, 96 and 144

    Boolean-based ACR/EULAR remission is achieved if all of the following requirements are met at the same timepoint: Tender Joint Count 68 (TJC68) <= 1, Swollen Joint Count 66 (SJC66) <= 1, high sensitivity C-reactive Protein (hsCRP) <= 1mg/dl and patient's global assessment of disease activity (PtGA) <= 10. Simple Disease Activity Index based ACR/EULAR remission is achieved if a has SDAI <= 3.3. The SDAI is the sum of the tender/painful joint count and swollen joint count, employing 28 joints; PtGA and PhGA (on a scale of 0-10); and hsCRP (mg/L). Percentage values are rounded off.

    Measured: Week 24, 48, 96 and 144

  6. Absolute Values for Clinical Disease Activity Index (CDAI) Total Score

    CDAI total score is a composite score consisting of the sum of TJC28, TJC28, PtGA (visual analogue scale with values from 0=best to 100=worst) and PhGA (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity.

    Measured: Week 24, 48, 96 and 144

  7. Absolute Values for Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP)

    The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28- PtGA is transformed to a 0-10 scale before computing the total score. CRP scores range from 1.0 to 9.4, where lower scores indicate less disease activity.

    Measured: Week 24, 48, 96 and 144

  8. Absolute Values for Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR)

    The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in millimeter [mm]/hour[hr]), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). PtGA is transformed to a 0-10 scale before computing the total score. DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity.

    Measured: Week 24, 48, 96 and 132

  9. Absolute Values of Van Der Heijde Modified Total Sharp Scores (mTSS)

    Van der Heijde mTSS is utilized for scoring radiographs of hands and feet in rheumatoid arthritis. This method includes 16 areas of erosions, and 15 areas for joint space narrowing (JSN) in each hand, and 6 areas for erosions and 6 areas JSN in each foot. The total mTSS score is the sum of erosion (maximum of 280) and JSN (maximum of 168) scores. The score ranges from 0 to 448 for mTSS with higher values representing higher disease activity.

    Measured: Week 24 and 48

  10. Absolute Values for Health Assessment Questionnaire Disability Index (HAQ-DI)

    The HAQ-DI includes 20 questions which assesses difficulty in performing activities of daily living. The questionnaire assesses eight domains of physical functioning: Dressing and Grooming, Hygiene, Arising, Reach, Eating, Grip, Walking, Common Daily Activities. The questions assess domain scores ranging from 0 "without any difficulty" to 3 "unable to do." Scores on each domain were summed and averaged to provide an overall score ranging from 0 to 3, where higher score reflected worse status and a lower score indicates better quality of life.

    Measured: Week 24, 48, 96 and 144

  11. Absolute Values for Arthritis Pain Visual Analogue Scale (VAS)

    For the Arthritis Pain VAS, participants assess the severity of their current arthritis pain using a continuous visual analogue scale (VAS) with anchors at "0" (no pain) and "100" (most severe pain). A negative change from baseline indicates an improvement.

    Measured: Week 24, 48, 96 and 144

  12. Absolute Values Short Form (SF)-36 Mental Component Scores (MCS)

    SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning,bodily pain,role limitations due to physical/emotional problems,general health,mental health(MH),social functioning(SF),vitality.Each of 8 domains is scored using average, 0-100; higher score represents better health.MCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health. MCS is primarily derived from 4 domains (SF,vitality,MH,role-emotional) representing overall mental health. Quality Metric software was used for scoring.

    Measured: Week 24, 48, 96 and 144

  13. Absolute Values SF-36 Domain Scores

    Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The MCS consists of 4 domains (social functioning, vitality, mental health, and role-emotional domains) and PCS consists of 4 domains (physical functioning, role-physical, bodily pain and general health). The individual question items are first summed for each item under the various sections. Then, those domain scores are weighted to a scale between 0 to 100, where higher score represents better health. Quality Metric software was used for scoring for SF-36.

    Measured: Week 24, 48, 96 and 144

  14. Absolute Values SF-36 Physical Component Scores (PCS)

    SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning(PF),bodily pain(BP),role limitations due to physical/emotional problems,general health(GH),mental health,social functioning,vitality.Each of 8 domains is scored using average, 0-100; higher score represents better health.PCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health.PCS is primarily derived from 4 domains(PF,role-physical,BP,GH) representing overall physical health. Quality Metric software was used for scoring.

    Measured: Week 24, 48, 96 and 144

  15. Absolute Values Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue

    The Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue is a validated patient-reported measure of 13 statements regarding the feeling of fatigue. The total score ranges from 0 to 52 with higher values representing a lower fatigue and a better quality of life.

    Measured: Week 24, 48, 96 and 144

  16. Number of Participants With Anti-GSK3196165 Antibodies

    Serum samples were collected for the determination of anti- GSK3196165 antibodies (ADA) using a validated electrochemiluminescence (ECL) immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Additionally, confirmed positive ADA samples were also tested in a validated neutralizing antibody assay to determine the potential neutralizing activity of the ADA

    Measured: Week 120

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2020
  2. Study start12 May 2020
  3. Primary completion24 Feb 2023
  4. Study completion24 Feb 2023

Why it stopped: Study is early terminated due to Limited efficacy demonstrated in the contRAst program does not support a suitable benefit/risk profile for otilimab as a potential treatment for RA. GSK has decided not to progress with regulatory submissions.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants who received GSK3196165 in their qualifying study will continue in this study on the same dose. Participants who received a comparator (tofacitinib or sarilumab) in their qualifying study will be centrally randomized using interactive response technology (IRT) in a ratio of 1:1 to either GSK3196165 90 mg or 150 mg.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
2,916 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04333147
Sponsor's protocol ID
209564
Acronym
contRAst X
Status last verified
Jan 2024
First submitted
27 Mar 2020
Last updated
7 Feb 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

  • Weinblatt ME, Taylor PC, McInnes IB, Atsumi T, Strand V, Takeuchi T, Bracher M, Brooks D, Curtis P, Gupta A, Nijhawan R, O'Shea C, Rayner K, Saurigny D, Shelton C, Wang M, Wang R, Fleischmann RM. Long-term safety and efficacy of anti-GM-CSF otilimab in patients with rheumatoid arthritis: long-term extension of three phase 3 randomised trials (contRAst X). BMJ Open. 2025 Mar 5;15(3):e088869. doi: 10.1136/bmjopen-2024-088869.

    PubMed 40044198

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Otilimab (GSK3196165) and csDMARD(s) in people with Arthritis, Rheumatoid, run by GlaxoSmithKline at 375 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 375 sites in United States, Japan, Poland, China, Argentina and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) (time frame: Up to approximately 145 Weeks). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04333147, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.

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