AzTrials
AzTrials

Rheumatoid ArthritisPhase 3NCT01194414

A Study to Compare Subcutaneous Versus Intravenous Administration of RoActemra/Actemra (Tocilizumab) in Participants With Moderate to Severe Active Rheumatoid Arthritis

A Phase 3 study testing tocilizumab SC, tocilizumab IV and Disease-modifying antirheumatic drugs (DMARDs) in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 216 sites in 26 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This randomized, double-blind, parallel group study compares the efficacy and safety of subcutaneous (sc) versus intravenous (iv) administration of tocilizumab in participants with moderate to severe active rheumatoid arthritis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
tocilizumab SC, tocilizumab IV and Disease-modifying antirheumatic drugs (DMARDs)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,262 participants
Where
216 sitesin 26 countries
Study dates
Sep 2010to Aug 2013
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

  • Adult participants, ≥ 18 years of age
  • Rheumatoid arthritis of ≥ 6 months duration, according to American College of Rheumatology (ACR) criteria
  • Swollen joint count (SJC) ≥ 4 (66 joint count), tender joint count (TJC) ≥ 4 (68 joint count) at screening and baseline
  • Inadequate response to current DMARD therapy
  • Permitted DMARDs must be at stable dose for ≥ 8 weeks prior to baseline
  • Oral corticosteroids (≤ 10 mg/day prednisone or equivalent) and NSAIDs (up to maximum recommended dose) must be at stable dose for ≥ 4 weeks prior to baseline

Who cannot join

  • Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization
  • Rheumatic autoimmune disease other than RA
  • Functional class IV (ACR classification)
  • Diagnosis of juvenile idiopathic arthritis (JIA) or juvenile rheumatoid arthritis (JRA) and/or RA before the age of 16
  • Prior history of or current inflammatory joint disease other than RA
  • Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline
  • Previous treatment with tocilizumab
  • Active current or history of recurrent infection

Trial locations and contacts

216 sites in 26 countries.

216 sites in 26 countries

United States54 sites

  • Study site

    Albany, New York, 12206

  • Study site

    Albuquerque, New Mexico, 87102

  • Study site

    Asheville, North Carolina, 28803

  • Study site

    Bethlehem, Pennsylvania, 18015

  • Study site

    Binghamton, New York, 13905

  • Study site

    Bridgeport, Connecticut, 06606

  • Study site

    Charleston, South Carolina, 29406

  • Study site

    Charleston, South Carolina, 29407

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Clifton, New Jersey, 07012

  • Study site

    Coeur d'Alene, Idaho, 83814

  • Study site

    Delray Beach, Florida, 33484

  • Study site

    Denver, Colorado, 80230-7127

  • Study site

    Eagan, Minnesota, 55121

  • Study site

    Florissant, Missouri, 63031

  • Study site

    Houston, Texas, 77004

  • Study site

    Huntsville, Alabama, 35801

  • Study site

    Knoxville, Tennessee, 37909

  • Study site

    Lebanon, New Hampshire, 03756

  • Study site

    Long Beach, California, 90806

  • Study site

    Los Angeles, California, 90048

  • Study site

    Manalapan, New Jersey, 07726

  • Study site

    Memphis, Tennessee, 38119

  • Study site

    Miami, Florida, 33133

  • Study site

    Monroe, Louisiana, 71203

  • Study site

    Morton Grove, Illinois, 60053

  • Study site

    Ocala, Florida, 34474

  • Study site

    Oklahoma City, Oklahoma, 73103

  • Study site

    Olympia, Washington, 98502

  • Study site

    Orchard Park, New York, 14127

  • Study site

    Orlando, Florida, 32806

  • Study site

    Palm Harbor, Florida, 34684

  • Study site

    Petoskey, Michigan, 49770

  • Study site

    Pinellas Park, Florida, 33782

  • Study site

    Raleigh, North Carolina, 27609

  • Study site

    Saint Claire Shores, Michigan, 48081

  • Study site

    San Antonio, Texas, 78217

  • Study site

    Seattle, Washington, 98122

  • Study site

    South Miami, Florida, 33143

  • Study site

    Spokane, Washington, 99204

  • Study site

    St Louis, Missouri, 63117

  • Study site

    St Louis, Missouri, 63131

  • Study site

    Tampa, Florida, 33614

  • Study site

    Toledo, Ohio, 43623

  • Study site

    Tucson, Arizona, 85704

  • Study site

    Tucson, Arizona, 85712

  • Study site

    Tulsa, Oklahoma, 74135

  • Study site

    Tuscaloosa, Alabama, 35406

  • Study site

    Upland, California, 91786

  • Study site

    Van Nuys, California, 91405

  • Study site

    Voorhees Township, New Jersey, 08043

  • Study site

    Wenatchee, Washington, 98801

  • Study site

    Wichita, Kansas, 67208

  • Study site

    Wilmington, North Carolina, 28401

Other trials in United States

Canada17 sites

  • Study site

    Edmonton, Alberta, T5H 3V9

  • Study site

    Hamilton, Ontario, L8N 1Y2

  • Study site

    Hamilton, Ontario, L8N 2B6

  • Study site

    Kelowna, British Columbia, V1Y 3G8

  • Study site

    Kitchener, Ontario, N2M 5N6

  • Study site

    Montreal, Quebec, H2L 1S6

  • Study site

    Ottawa, Ontario, K1Y 4G2

  • Study site

    Québec, Quebec, G1V 3M7

  • Study site

    Rimouski, Quebec, G5L 3W1

  • Study site

    Sainte-Foy, Quebec, G1W 4R4

  • Study site

    Saskatoon, Saskatchewan, S7K 0H6

  • Study site

    St. Catharines, Ontario, L2N 7E4

  • Study site

    St. John's, Newfoundland and Labrador, A1A 5E8

  • Study site

    St. John's, Newfoundland and Labrador, A1C 5B8

  • Study site

    Trois-Rivières, Quebec, G8Z 1Y2

  • Study site

    Vancouver, British Columbia, V5Z 1L7

  • Study site

    Windsor, Ontario, N8X 5A6

Other trials in Canada

Germany16 sites

  • Study site

    Bad Bramstedt, 24576

  • Study site

    Berlin, 10117

  • Study site

    Berlin, 14059

  • Study site

    Cologne, 50924

  • Study site

    Dresden, 01067

  • Study site

    Essen, 45239

  • Study site

    Freiburg im Breisgau, 79106

  • Study site

    Gommern, 39245

  • Study site

    Heidelberg, 69120

  • Study site

    Herne, 44652

  • Study site

    Hildesheim, 31134

  • Study site

    Ludwigshafen, 67063

  • Study site

    Osnabrück, 49074

  • Study site

    Ratingen, 40882

  • Study site

    Rostock, 18059

  • Study site

    Würzburg, 97080

Other trials in Germany

United Kingdom14 sites

  • Study site

    Cambridge, CB2 2QQ

  • Study site

    Cannock, WS11 5XY

  • Study site

    Coventry, CV2 2DX

  • Study site

    Eastbourne, BN21 2UD

  • Study site

    Exeter, EX2 5DW

  • Study site

    Harrogate, HG2 7SX

  • Study site

    Ipswich, IP4 5PD

  • Study site

    London, E11 1NR

  • Study site

    Metropolitan Borough of Wirral, CH49 5PE

  • Study site

    Middlesbrough, TS4 3BW

  • Study site

    Newcastle upon Tyne, NE7 7DN

  • Study site

    Northampton, NN1 5BD

  • Study site

    Nottingham, NG7 2UH

  • Study site

    Westcliffe-on-sea, SS0 0RY

Other trials in United Kingdom

Spain13 sites

  • Study site

    A Coruña, 15006

  • Study site

    Barakaldo, 48903

  • Study site

    Bilbao, 48013

  • Study site

    Madrid, 28007

  • Study site

    Madrid, 28046

  • Study site

    Málaga, 29010

  • Study site

    Mérida, 97500

  • Study site

    San Cristóbal de La Laguna, 38320

  • Study site

    Santander, 39008

  • Study site

    Santiago de Compostela, 15706

  • Study site

    Seville, 41009

  • Study site

    Torrelavega, 39300

  • Study site

    Valencia, 46009

Other trials in Spain

Italy12 sites

  • Study site

    Arenzano, 16011

  • Study site

    Bergamo, 24128

  • Study site

    Catania, 95124

  • Study site

    Cona (ferrara), 44124

  • Study site

    Genova, 16132

  • Study site

    Naples, 80131

  • Study site

    Pavia, 27100

  • Study site

    Pisa, 56100

  • Study site

    Potenza, 85100

  • Study site

    Reggio Emilia, 42100

  • Study site

    Udine, 33100

  • Study site

    Varese, 21100

Other trials in Italy

Mexico12 sites

  • Study site

    Culiacán, 80000

  • Study site

    Guadalajara, 44629

  • Study site

    Guadalajara, 44690

  • Study site

    León, 37000

  • Study site

    Mérida, 97000

  • Study site

    Mexico Ctiy, 07760

  • Study site

    Miexico City, 06700

  • Study site

    Morelia, 58070

  • Study site

    Obregón, 85000

  • Study site

    Querétaro, 76178

  • Study site

    Saltillo, 25000

  • Study site

    Torreón, 27000

Other trials in Mexico

Russia9 sites

  • Study site

    Moscow, 115522

  • Study site

    Moscow, 119991

  • Study site

    Novosibirsk, 630099

  • Study site

    Novosibirsk, 630117

  • Study site

    Ryazan, 390026

  • Study site

    Saint Petersburg, 190068

  • Study site

    Ulyanovsk, 432600

  • Study site

    Yaroslavl, 150030

  • Study site

    Yaroslavl, 150062

Other trials in Russia

Australia8 sites

  • Study site

    Adelaide, 5011

  • Study site

    Adelaide, 5041

  • Study site

    Clayton, 3168

  • Study site

    Geelong, 3220

  • Study site

    Hobart, 7000

  • Study site

    Malvern East, 3145

  • Study site

    Maroochydore, 4558

  • Study site

    New Lambton, 2305

Other trials in Australia

Brazil8 sites

  • Study site

    Curitiba, 80060-240

  • Study site

    Goiânia, 74110010

  • Study site

    Juiz de Fora, 36010-570

  • Study site

    Porto Alegre, 90035-903

  • Study site

    Porto Alegre, 90610-000

  • Study site

    São Paulo, 04039-000

  • Study site

    São Paulo, 05403-000

  • Study site

    São Paulo, 4037003

Other trials in Brazil

France8 sites

  • Study site

    Bordeaux, 33076

  • Study site

    Le Mans, 72037

  • Study site

    Marseille, 13285

  • Study site

    Montpellier, 34295

  • Study site

    Nantes, 44035

  • Study site

    Paris, 75679

  • Study site

    Strasbourg, 67098

  • Study site

    Toulouse, 31059

Other trials in France

South Africa5 sites

  • Study site

    Cape Town, 7500

  • Study site

    Durban, 4001

  • Study site

    Parktown, 2000

  • Study site

    Port Elizabeth, 6045

  • Study site

    Stellenbosch, 7600

Other trials in South Africa

Argentina4 sites

  • Study site

    Buenos Aires, B1878DVB

  • Study site

    Buenos Aires, C1015ABO

  • Study site

    Buenos Aires, C1428DQG

  • Study site

    Rosario, S2000PBJ

Other trials in Argentina

New Zealand4 sites

  • Study site

    Auckland, 2025

  • Study site

    Hamilton, 3240

  • Study site

    Tauranga, 3112

  • Study site

    Wellington, 6035

Other trials in New Zealand

Poland4 sites

  • Study site

    Bialystok, 15-351

  • Study site

    Lublin, 20-954

  • Study site

    Poznan, 60-218

  • Study site

    Warsaw, 01-157

Other trials in Poland

Romania4 sites

  • Study site

    Bucharest, 011172

  • Study site

    Bucharest, 020475

  • Study site

    Bucharest, 020983

  • Study site

    Iași, 700661

Other trials in Romania

Thailand4 sites

  • Study site

    Bangkok, 10400

  • Study site

    Bangkok, 10700

  • Study site

    Chiang Mai, 50200

  • Study site

    Khon Kaen, 40002

Other trials in Thailand

Bulgaria3 sites

  • Study site

    Sofia, 1606

  • Study site

    Sofia, 1612

  • Study site

    Sofia, 1784

Other trials in Bulgaria

Lithuania3 sites

  • Study site

    Klaipėda, 92288

  • Study site

    Šiauliai, 76231

  • Study site

    Vilnius, LT-08661

Other trials in Lithuania

Peru3 sites

  • Study site

    Lima, 01

  • Study site

    Lima, LIMA 14

  • Study site

    Lima, Lima 41

Other trials in Peru

Philippines3 sites

  • Study site

    Cebu, 6000

  • Study site

    Manila, 1000

  • Study site

    Quezon, 1102

Other trials in Philippines

Colombia2 sites

  • Study site

    Barranquilla

  • Study site

    Bogotá

Other trials in Colombia

Guatemala2 sites

  • Study site

    Guatemala City, 01010

  • Study site

    Guatemala City, 01015

Other trials in Guatemala

Hong Kong2 sites

  • Study site

    Hong Kong, 852

  • Study site

    Hong Kong

Other trials in Hong Kong

Puerto Rico1 site

  • Study site

    Ponce, 00716

Other trials in Puerto Rico

Singapore1 site

  • Study site

    Singapore, 119074

Other trials in Singapore

About this study

Official title: A Randomized, Double-blind, Parallel Group Study of the Safety and Effect on Clinical Outcome of Tocilizumab SC Versus Tocilizumab IV, in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs), in Patients With Moderate to Severe Active Rheumatoid Arthritis

This randomized, double-blind, parallel group study compares the efficacy and safety of subcutaneous (sc) versus intravenous (iv) administration of tocilizumab in participants with moderate to severe active rheumatoid arthritis. Participants were randomized to receive either tocilizumab 162 mg sc weekly plus iv placebo every 4 weeks, or tocilizumab 8 mg/kg iv every 4 weeks plus sc placebo weekly during the double-blind period from baseline to Week 24. The double-blind period was followed by a 72-week open-label treatment with some switching of sc and iv administration. No placebo was administered in the open-label phase. Participants continued on their stable dose of disease-modifying antirheumatic drugs (DMARDs) throughout the study. Anticipated time on study treatment was 2 years.

Being tested
tocilizumab SC, tocilizumab IV, placebo to tocilizumab SC, placebo to tocilizumab IV, Disease-modifying antirheumatic drugs (DMARDs)
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • tocilizumab SCDrug

    Also called RoActemra/Actemra

    Tocilizumab supplied in a single-use pre-filled syringe, with a needle safety device, delivering 162 mg/0.9 mL solution for subcutaneous injection once a week.

  • tocilizumab IVDrug

    Also called RoActemra/Actemra

    Tocilizumab supplied in vials as a sterile solution for 8 mg/kg intravenous infusion every 4 weeks.

  • placebo to tocilizumab SCDrug

    Placebo tocilizumab supplied as a single-use pre-filled syringe with a needle safety device, delivering 0.9 mL sodium chloride for subcutaneous injection once a week for 24 weeks in the double-blind period.

  • placebo to tocilizumab IVDrug

    Placebo to tocilizumab supplied as a solution in 10 mL vials containing polysorbate 80 and sucrose in water for infusion every 4 weeks for a total of 24 weeks in the double-blind period.

  • Disease-modifying antirheumatic drugs (DMARDs)Drug

    stable dose as prescribed

Study groups in NCT01194414
Study groupRoleWhat they receive
Tocilizumab SCExperimentalParticipants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
Receives: Drug: tocilizumab SC; Drug: placebo to tocilizumab IV; Drug: Disease-modifying antirheumatic drugs (DMARDs)
Tocilizumab IVExperimentalParticipants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
Receives: Drug: tocilizumab IV; Drug: placebo to tocilizumab SC; Drug: Disease-modifying antirheumatic drugs (DMARDs)
Tocilizumab SC Then Tocilizumab IVExperimentalParticipants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
Receives: Drug: tocilizumab SC; Drug: tocilizumab IV; Drug: placebo to tocilizumab IV; Drug: Disease-modifying antirheumatic drugs (DMARDs)
Tocilizumab IV Then Tocilizumab SCExperimentalParticipants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study.
Receives: Drug: tocilizumab SC; Drug: tocilizumab IV; Drug: placebo to tocilizumab SC; Drug: Disease-modifying antirheumatic drugs (DMARDs)

What is being measured

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

  1. Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR20) Response at Week 24

    ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the five additional ACR core set variables: Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) where left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either C-reactive protein [CRP] or Erythrocyte Sedimentation Rate [ESR]).

    Measured: Baseline, 24 weeks

  2. Percentage of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Assessments

    Measured: Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)

Secondary outcomes (17)

  1. Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR50) Response at Week 24

    ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the five additional ACR core set variables: Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) where left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either C-reactive protein or Erythrocyte Sedimentation Rate).

    Measured: Baseline, 24 weeks

  2. Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR70) Response at Week 24

    ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the five additional ACR core set variables: Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) where left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either C-reactive protein or Erythrocyte Sedimentation Rate).

    Measured: Baseline, 24 weeks

  3. Percentage of Participants With Disease Activity Score 28 (DAS28) Remission at Week 24

    The DAS28 (ESR) score is a measure of the subject's disease activity. It is calculated using the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity VAS where left side of the line 0=no disease activity to right side of the line 100=extreme disease activity and ESR. DAS28-(ESR) total scores range from 0 - 10. Remission is defined as achieving a DAS28-ESR score of less than 2.6.

    Measured: Week 24

  4. Percentage of Participants Achieving a Decrease of ≥ 0.3 in the Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 24

    The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a participant completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A decrease indicates improvement.

    Measured: Baseline, 24 Weeks

  5. Percentage of Participants Who Withdrew Because of Lack of Therapeutic Response at Week 24

    The percentage of participants who withdrew from the study because they were not responding to treatment with the study drug.

    Measured: 24 Weeks

  6. Percentage of Participants With American College of Rheumatology Criteria (ACR20, ACR50, ACR70) at Week 97

    ACR20, ACR50 and ACR70: ≥20%, ≥50% and ≥70% reduction from baseline for both TJC68 and SJC66, as well as for 3 of 5 additional ACR variables: Patient's Assessment of Pain in last 24 hours using a Visual Analog Scale (VAS) (0=no pain and 100=unbearable pain); Patient's and Physician's Global Assessment of Disease Activity in last 24 hours using a VAS (0=no disease activity and100=maximum disease activity); Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either CRP or ESR). CRP was used for calculation of ACR. If missing, ESR was used. LOCF was used for missing joint counts, no imputation for other ACR components.

    Measured: Week 97

  7. Percentage of Participants With Disease Activity Score 28 (DAS28) Remission at Week 97

    The DAS28 (ESR) score is a measure of the subject's disease activity. It is calculated using the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity VAS where left side of the line 0=no disease activity to right side of the line 100=extreme disease activity and ESR. DAS28-(ESR) total scores range from 0 - 10. Remission is defined as achieving a DAS28-ESR score of less than 2.6. LOCF used for tender and swollen joint counts, no imputation used for ESR and Patient's Global Assessment of Disease Activity VAS.

    Measured: Week 97

  8. Percentage of Participants Achieving a Decrease of ≥0.3 in the Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 97

    The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A decrease indicates improvement. No imputation of missing scores was made other than for missing baseline scores, for which last score prior to baseline will be carried forward. For participants who prematurely withdrew, data collected at withdrawal visit was used and data thereafter is missing.

    Measured: Baseline, Week 97

  9. Percentage of Participants Who Withdrew Because of Lack of Therapeutic Response at Week 97

    The percentage of participants who withdrew from the study because they were not responding to treatment with the study drug.

    Measured: Week 97

  10. Area Under the Serum Concentration Curve of Tocilizumab After First SC Injection or IV Infusion

    Measured: Week 0: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after first dose

  11. Area Under the Serum Concentration Curve of Tocilizumab at Steady State for SC and IV Treatment

    Measured: Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose.

  12. Minimum Serum Concentration (Cmin) of Tocilizumab

    Measured: Week 0, Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose

  13. Maximum Serum Concentration (Cmax) of Tocilizumab

    Measured: Week 0, Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose

  14. Time to Maximum Serum Concentration (Tmax) of Tocilizumab

    Measured: Week 0, Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose

  15. Change From Baseline in Serum Interleukin-6 (IL-6) Concentration at Week 25

    Measured: Baseline, Week 25

  16. Change From Baseline in Serum Soluble Interleukin-6 Receptor (sIL-6R) Concentration at Week 97

    Measured: Baseline, Week 97

  17. Percentage of Participants Who Developed Antibodies To Tocilizumab at Week 97

    Measured: Week 97

Timeline

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

  1. First posted3 Sep 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionJan 2012
  4. Study completionAug 2013

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
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,262 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01194414
Sponsor's protocol ID
WA22762
Other IDs
2010-018375-22
Status last verified
Sep 2013
First submitted
1 Sep 2010
Last updated
20 Jun 2016

Publications

  • Burmester GR, Rubbert-Roth A, Cantagrel A, Hall S, Leszczynski P, Feldman D, Rangaraj MJ, Roane G, Ludivico C, Bao M, Rowell L, Davies C, Mysler EF. Efficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97 (SUMMACTA). Ann Rheum Dis. 2016 Jan;75(1):68-74. doi: 10.1136/annrheumdis-2015-207281. Epub 2015 Jun 8.

    PubMed 26056119

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing tocilizumab SC, tocilizumab IV and Disease-modifying antirheumatic drugs (DMARDs) in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 216 sites in 26 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 20 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 216 sites in United States, Canada, Germany, United Kingdom, Spain and 21 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 12 Feb 2013). 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?

Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR20) Response at Week 24 (time frame: Baseline, 24 weeks). The study lists 2 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 NCT01194414, 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 20 Jun 2016.

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