AzTrials
AzTrials

Rheumatoid ArthritisPhase 3NCT00720798

An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies

A Phase 3 study testing Tocilizumab, Disease-modifying anti-rheumatic drugs and Non-steroidal anti-inflammatory drugs in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 295 sites in 34 countries.

Completed

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

Official record
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Trial summary

This single-arm study evaluated the long-term efficacy and safety of tocilizumab in participants who had completed treatment in the tocilizumab core studies (NCT00106522 [Roche protocol WA18062], NCT00106574 [Roche protocol WA18063], and NCT00109408 [Roche protocol WA17824]) of adults with 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, Disease-modifying anti-rheumatic drugs and Non-steroidal anti-inflammatory drugs
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,067 participants
Where
295 sitesin 34 countries
Study dates
Sep 2005to Apr 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

  • Patients who have completed participation in 1 of the core studies in adult rheumatoid arthritis.

Who cannot join

  • Treatment with any investigational agent since the last administration of study drug in the core studies.
  • Treatment with iv gamma globulin, plasmapheresis, or prosorba column since the last administration of study drug in the core studies.
  • Treatment with an anti-TNF or anti-IL1 agent, a T-cell co-stimulation modulator, or any biologic since the last administration of study drug in the core studies.
  • Immunization with a live/attenuated vaccine since the last administration of study drug in the core studies.
  • Previous treatment with any cell-depleting therapies, including investigational agents.
  • Parenteral, intramuscular, or intra-articular corticosteroids within 6 weeks prior to baseline in this study.

Trial locations and contacts

295 sites in 34 countries.

295 sites in 34 countries

United States138 sites

  • Study site

    Albany, New York, 12206

  • Study site

    Albuquerque, New Mexico, 87131

  • Study site

    Allentown, Pennsylvania, 18103

  • Study site

    Amarillo, Texas, 79124

  • Study site

    Anaheim, California, 92801

  • Study site

    Asheville, North Carolina, 28803

  • Study site

    Atlanta, Georgia, 30342

  • Study site

    Austin, Texas, 78705

  • Study site

    Austin, Texas, 78749

  • Study site

    Aventura, Florida, 33180

  • Study site

    Baton Rouge, Louisiana, 70808

  • Study site

    Bethlehem, Pennsylvania, 18015

  • Study site

    Billings, Montana, 59107-5100

  • Study site

    Binghamton, New York, 13905

  • Study site

    Birmingham, Alabama, 35294-7201

  • Study site

    Bismarck, North Dakota, 58501

  • Study site

    Boise, Idaho, 83702

  • Study site

    Boston, Massachusetts, 02111

  • Study site

    Bowling Green, Kentucky, 42102

  • Study site

    Burlington, Vermont, 05401

  • Study site

    Canton, Ohio, 44718

  • Study site

    Cedar Rapids, Iowa, 52401

  • Study site

    Chapel Hill, North Carolina, 27599-7280

  • Study site

    Charleston, South Carolina, 29406

  • Study site

    Charlotte, North Carolina, 28210

  • Study site

    Chesapeake, Virginia, 23320

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Cleveland, Ohio, 44109

  • Study site

    Colorado Springs, Colorado, 80910

  • Study site

    Columbia, South Carolina, 29204

  • Study site

    Dallas, Texas, 75231-4406

  • Study site

    Dallas, Texas, 75231

  • Study site

    Danville, Pennsylvania, 17822

  • Study site

    Dayton, Ohio, 45408

  • Study site

    Delray Beach, Florida, 33484

  • Study site

    Des Moines, Iowa, 50322

  • Study site

    Dover, New Hampshire, 03820

  • Study site

    Duncansville, Pennsylvania, 16635

  • Study site

    Durham, North Carolina, 27704

  • Study site

    Eagan, Minnesota, 55121

  • Study site

    Eugene, Oregon, 97401

  • Study site

    Flowood, Mississippi, 39232

  • Study site

    Fort Lauderdale, Florida, 33334

  • Study site

    Frederick, Maryland, 21702

  • Study site

    Glendale, Wisconsin, 53217

  • Study site

    Grand Rapids, Michigan, 49546

  • Study site

    Great Neck, New York, 11020

  • Study site

    Greenville, South Carolina, 29601

  • Study site

    Haddon Heights, New Jersey, 08035

  • Study site

    Hickory Grove, South Carolina, 28602

  • Study site

    Hixson, Tennessee, 37343

  • Study site

    Houston, Texas, 77074

  • Study site

    Huntsville, Alabama, 35801

  • Study site

    Idaho Falls, Idaho, 83404

  • Study site

    Indianapolis, Indiana, 46202-5149

  • Study site

    Jackson, Tennessee, 38305

  • Study site

    Johnston, Rhode Island, 02919

  • Study site

    Kalamazoo, Michigan, 49048

  • Study site

    La Crosse, Wisconsin, 54601

  • Study site

    Lansing, Michigan, 48910

  • Study site

    Lexington, Kentucky, 40515

  • Study site

    Lincoln, Nebraska, 68516

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Long Beach, California, 90806

  • Study site

    Long Beach, California, 90808

  • Study site

    Los Angeles, California, 90045

  • Study site

    Los Angeles, California, 90095

  • Study site

    Louisville, Kentucky, 40202

  • Study site

    Medford, Oregon, 97504

  • Study site

    Meridian, Idaho, 83642

  • Study site

    Mesa, Arizona, 85208

  • Study site

    Mesquite, Texas, 75150

  • Study site

    Morton Grove, Illinois, 60053

  • Study site

    Mountlake Terrace, Washington, 98043

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    New Brunswick, New Jersey, 08903

  • Study site

    New York, New York, 10021

  • Study site

    Newark, Delaware, 19713

  • Study site

    Norfolk, Virginia, 23502

  • Study site

    Oklahoma City, Oklahoma, 73103

  • Study site

    Oklahoma City, Oklahoma, 73109

  • Study site

    Oklahoma City, Oklahoma, 73112

  • Study site

    Olympia, Washington, 98502

  • Study site

    Orchard Park, New York, 14127

  • Study site

    Palm Desert, California, 92260

  • Study site

    Palm Habor, Florida, 34684

  • Study site

    Palm Harbor, Florida, 34684

  • Study site

    Palm Springs, California, 92262

  • Study site

    Palo Alto, California, 94304

  • Study site

    Paradise Valley, Arizona, 85253

  • Study site

    Passaic, New Jersey, 07055

  • Study site

    Peoria, Arizona, 85381

  • Study site

    Philadelphia, Pennsylvania, 19152

  • Study site

    Pittsburgh, Pennsylvania, 15261

  • Study site

    Pittsfield, Massachusetts, 01201

  • Study site

    Plainview, New York, 11803

  • Study site

    Portland, Maine, 04102

  • Study site

    Raleigh, North Carolina, 27609

  • Study site

    Reno, Nevada, 89502

  • Study site

    Rochester, New York, 14642

  • Study site

    Saint Cloud, Minnesota, 56303

  • Study site

    Saint Louis Park, Minnesota, 55426

  • Study site

    San Diego, California, 92101

  • Study site

    San Diego, California, 92108

  • Study site

    San Jose, California, 95126

  • Study site

    San Leandro, California, 94578

  • Study site

    Santa Maria, California, 93454

  • Study site

    Sarasota, Florida, 34239

  • Study site

    Scottsdale, Arizona, 85251

  • Study site

    Scottsdale, Arizona, 85258

  • Study site

    Seattle, Washington, 98104

  • Study site

    Seattle, Washington, 98195

  • Study site

    Shreverport, Louisiana, 71103

  • Study site

    Slidell, Louisiana, 70458

  • Study site

    Spokane, Washington, 99204

  • Study site

    Springfield, Illinois, 62704

  • Study site

    Springfield, Missouri, 65807

  • Study site

    St Louis, Missouri, 63117

  • Study site

    St Louis, Missouri, 63128

  • Study site

    St Louis, Missouri, 63131

  • Study site

    St Louis, Missouri, 63141

  • Study site

    Syracuse, New York, 13210

  • Study site

    Tacoma, Washington, 98405

  • Study site

    Tampa, Florida, 33609

  • Study site

    Tampa, Florida, 33614

  • Study site

    Torrance, California, 90505

  • Study site

    Tucson, Arizona, 85723

  • Study site

    Tucson, Arizona, 85724

  • Study site

    Tulsa, Oklahoma, 74104

  • Study site

    Tulsa, Oklahoma, 74135

  • Study site

    Tupelo, Mississippi, 38802

  • Study site

    Upland, California, 91786

  • Study site

    Vernon Hills, Illinois, 60061

  • Study site

    West Palm Beach, Florida, 33407

  • Study site

    Wheaton, Maryland, 20902

  • Study site

    Willow Grove, Pennsylvania, 19090

  • Study site

    Willow Grove, Pennsylvania, 80045

  • Study site

    Wyomissing, Pennsylvania, 19610

Other trials in United States

France20 sites

  • Study site

    Amiens, 80054

  • Study site

    Bordeaux, 33076

  • Study site

    Boulogne-Billancourt, 92104

  • Study site

    Brest, 29609

  • Study site

    Grenoble, 38042

  • Study site

    Le Kremlin-Bicêtre, 94270

  • Study site

    Lille, 59037

  • Study site

    Lyon, 69437

  • Study site

    Marseille, 13285

  • Study site

    Montpellier, 34295

  • Study site

    Nantes, 44035

  • Study site

    Nice, 06202

  • Study site

    Paris, 75181

  • Study site

    Paris, 75679

  • Study site

    Pierre-Bénite, 69495

  • Study site

    Rennes, 35203

  • Study site

    Rouen, 76031

  • Study site

    Saint-Priest-en-Jarez, 42277

  • Study site

    Strasbourg, 67098

  • Study site

    Toulouse, 31059

Other trials in France

Canada16 sites

  • Study site

    Burlington, Ontario, L7R 1E2

  • Study site

    Calgary, Alberta, T2V 1P9

  • Study site

    Edmonton, Alberta, T5H 3V9

  • Study site

    Hamilton, Ontario, L8N 2B6

  • Study site

    Kitchener, Ontario, N2M 5N6

  • Study site

    London, Ontario, N6A 4V2

  • Study site

    Mississauga, Ontario, L5M 2V8

  • Study site

    Montreal, Quebec, H2L 1S6

  • Study site

    Ottawa, Ontario, K1H 1A2

  • Study site

    Québec, Quebec, G1V 3M7

  • Study site

    Sainte-Foy, Quebec, G1W 4R4

  • Study site

    Saskatoon, Saskatchewan, S7N 0W8

  • Study site

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

  • Study site

    Toronto, Ontario, M5T 3L9

  • Study site

    Victoria, British Columbia, V8V 3P9

  • Study site

    Winnipeg, Manitoba, R3A 1M3

Other trials in Canada

Germany14 sites

  • Study site

    Aachen, 52064

  • Study site

    Berlin, 10117

  • Study site

    Cologne, 50924

  • Study site

    Dresden, 01067

  • Study site

    Essen, 45239

  • Study site

    Gommern, 39245

  • Study site

    Herne, 44652

  • Study site

    Hildesheim, 31134

  • Study site

    München, 80335

  • Study site

    München, 81541

  • Study site

    Osnabrück, 49074

  • Study site

    Sendenhorst, 48324

  • Study site

    Wiesbaden, 65191

  • Study site

    Würzburg, 97080

Other trials in Germany

United Kingdom13 sites

  • Study site

    Basingstoke, RG24 9NA

  • Study site

    Birmingham, B29 6JD

  • Study site

    Cannock, WS11 5XY

  • Study site

    Derby, DE1 2QY

  • Study site

    Leeds, LS7 4SA

  • Study site

    London, SE1 9RT

  • Study site

    Manchester, M13 9WL

  • Study site

    Manchester, M41 5SL

  • Study site

    Middlesbrough, TS4 3BW

  • Study site

    Newcastle upon Tyne, NE1 4LP

  • Study site

    Oxford, OX3 7LD

  • Study site

    Southampton, SO16 6YD

  • Study site

    Stoke-on-Trent, ST6 7AG

Other trials in United Kingdom

Italy8 sites

  • Study site

    Brescia, 25123

  • Study site

    Genova, 16132

  • Study site

    Milan, 20157

  • Study site

    Padova, 35128

  • Study site

    Pavia, 27100

  • Study site

    Pisa, 56100

  • Study site

    Siena, 53100

  • Study site

    Udine, 33100

Other trials in Italy

Mexico8 sites

  • Study site

    Guadalajara, 44340

  • Study site

    Guadalajara, 44620

  • Study site

    Guadalajara, 45235

  • Study site

    León, 37000

  • Study site

    Mexico City, 06700

  • Study site

    Mexico City, 07760

  • Study site

    Mexico City, 14050

  • Study site

    Tijuana, 22320

Other trials in Mexico

China7 sites

  • Study site

    Beijing, 100032

  • Study site

    Beijing, 100044

  • Study site

    Guangzhou, 510630

  • Study site

    Hefei Anhui, 230022

  • Study site

    Jinan, 250012

  • Study site

    Shanghai, 200127

  • Study site

    Shanghai, 200433

Other trials in China

Russia7 sites

  • Study site

    Moscow, 105203

  • Study site

    Moscow, 115522

  • Study site

    Moscow, 117049

  • Study site

    Ryazan, 390026

  • Study site

    Saint Petersburg, 190068

  • Study site

    Saint Petersburg, 191015

  • Study site

    Tula, 300053

Other trials in Russia

South Africa7 sites

  • Study site

    Cape Town, 4001

  • Study site

    Cape Town, 7500

  • Study site

    Diepkloof, 1862

  • Study site

    Durban, 4001

  • Study site

    Pinelands, 7405

  • Study site

    Pretoria, 0002

  • Study site

    Radiokop, 2040

Other trials in South Africa

Spain6 sites

  • Study site

    Barakaldo, 48903

  • Study site

    Barcelona, 08035

  • Study site

    Madrid, 28046

  • Study site

    Málaga, 29010

  • Study site

    Pontevedra, 36001

  • Study site

    Santiago de Compostela, 15706

Other trials in Spain

Australia5 sites

  • Study site

    Hobart, 7000

  • Study site

    Malvern, 3144

  • Study site

    Shenton Park, 6008

  • Study site

    Sydney, 2050

  • Study site

    Woolloongabba, 4102

Other trials in Australia

Lithuania5 sites

  • Study site

    Kaunas, 50009

  • Study site

    Klaipėda, 92288

  • Study site

    Panevezys, 35144

  • Study site

    Šiauliai, 76231

  • Study site

    Vilnius, LT-08661

Other trials in Lithuania

Argentina4 sites

  • Study site

    Buenos Aires, C1015ABO

  • Study site

    Buenos Aires, C1428DQG

  • Study site

    Rosario, S2000PBJ

  • Study site

    San Juan Bautista, B1878DVB

Other trials in Argentina

Israel4 sites

  • Study site

    Ashkelon, 78306

  • Study site

    Haifa, 31048

  • Study site

    Haifa, 34354

  • Study site

    Rishon LeZiyyon, 70300

Other trials in Israel

Brazil3 sites

  • Study site

    Campinas, 13060-803

  • Study site

    Goiânia, 74653-050

  • Study site

    Rio de Janeiro, 20551030

Other trials in Brazil

Czechia3 sites

  • Study site

    Hradec Králové, 500 05

  • Study site

    Prague, 128 50

  • Study site

    Prague, 140 59

Other trials in Czechia

Thailand3 sites

  • Study site

    Bangkok, 10330

  • Study site

    Bangkok, 10400

  • Study site

    Chiang Mai, 50200

Other trials in Thailand

Belgium2 sites

  • Study site

    Hasselt, 3500

  • Study site

    Merksem, 2170

Other trials in Belgium

Finland2 sites

  • Study site

    Helsinki, 00290

  • Study site

    Jyväskylä, 40620

Other trials in Finland

Hong Kong2 sites

  • Study site

    Hong Kong, 852

  • Study site

    Tuenmen, 852

Other trials in Hong Kong

Norway2 sites

  • Study site

    Levanger, 7600

  • Study site

    Lillehammer, 2609

Other trials in Norway

Peru2 sites

  • Study site

    Lima, 11

  • Study site

    Lima, 13

Other trials in Peru

Serbia2 sites

  • Study site

    Belgrade, 11000

  • Study site

    Niška Banja, 18250

Other trials in Serbia

Slovenia2 sites

  • Study site

    Ljubljana, 1000

  • Study site

    Maribor, 2000

Other trials in Slovenia

Sweden2 sites

  • Study site

    Stockholm, 17176

  • Study site

    Umeå, 90185

Other trials in Sweden

Costa Rica1 site

  • Study site

    San José, 10103

Other trials in Costa Rica

Denmark1 site

  • Study site

    Hellerup, 2900

Other trials in Denmark

Iceland1 site

  • Study site

    Reykjavik, 108

Other trials in Iceland

Netherlands1 site

  • Study site

    Nijmegen, 6525 GA

Other trials in Netherlands

Panama1 site

  • Study site

    Panama City, 32400

Other trials in Panama

Portugal1 site

  • Study site

    Lisbon, 1349-019

Other trials in Portugal

Puerto Rico1 site

  • Study site

    Ponce, 00716

Other trials in Puerto Rico

Switzerland1 site

  • Study site

    Lausanne, 1011

Other trials in Switzerland

About this study

Official title: Long-term Extension Study of Safety During Treatment With Tocilizumab (MRA) in Patients Completing Treatment in MRA Core Studies

This single-arm study evaluated the long-term efficacy and safety of tocilizumab in participants who had completed treatment in the tocilizumab core studies (NCT00106522 [Roche protocol WA18062], NCT00106574 [Roche protocol WA18063], and NCT00109408 [Roche protocol WA17824]) of adults with rheumatoid arthritis. Participants received tocilizumab alone or in combination with standard anti-rheumatic treatment.

Being tested
Tocilizumab, Disease-modifying anti-rheumatic drugs, Non-steroidal anti-inflammatory drugs, Oral corticosteroids
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • TocilizumabDrug

    Also called RoActemra, Actemra

    For participants weighing > 100 kg, the maximum dose of tocilizumab was 800 mg. Tocilizumab was supplied as a sterile solution in vials.

  • Disease-modifying anti-rheumatic drugsDrug

    Disease-modifying anti-rheumatic drugs included methotrexate, chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide. These drugs could be used alone or in combination, except for the combination of methotrexate and leflunomide, which was not allowed.

  • Non-steroidal anti-inflammatory drugsDrug

    Participants could be treated with non-steroidal anti-inflammatory drugs up to the maximum recommended dose throughout the study. The choice and doses of non-steroidal anti-inflammatory drugs were at the discretion of the investigator.

  • Oral corticosteroidsDrug

    Oral corticosteroids (≤ 10 mg/day) were permitted during the study.

Study groups in NCT00720798
Study groupRoleWhat they receive
TocilizumabExperimentalParticipants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Receives: Drug: Tocilizumab; Drug: Disease-modifying anti-rheumatic drugs; Drug: Non-steroidal anti-inflammatory drugs; Drug: Oral corticosteroids

What is being measured

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

  1. Percentage of Participants With ≥ 1 Adverse Event

    Measured: Baseline to the end of the study (up to 7 years, 7 months)

Secondary outcomes (15)

  1. Percentage of Participants Who Withdrew From Treatment

    Measured: Baseline to the end of the study (up to 7 years, 7 months)

  2. Percentage of Participants With Concomitant Oral Corticosteroid Therapy

    Concomitant therapy with oral corticosteroids (up 5 to 10 mg daily prednisone or equivalent) was permitted in the study. Reduction of oral corticosteroids was permitted, but not required, if a patient achieved at least a 50% improvement from baseline in both tender joint count and swollen joint count.

    The data are reported for each 6-month period of the study where a month = 28 days. The last 6-month period is for months 96 through 101. The actually study duration in 28-day months was 98.85 months.

    Measured: Baseline to the end of the study (up to 7 years, 7 months)

  3. Percentage of Participants Who Changed From Monotherapy to Combination Therapy

    Participants who entered this study from study WA17824 on tocilizumab monotherapy, who did not achieve a 50% reduction in tender and swollen joint counts from Baseline of study WA17824, could add methotrexate or another allowable disease-modifying anti-rheumatic drug, according to the investigator's practice and as tolerated by the patient, at any time during this study.

    Measured: Baseline to Week 296

  4. Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264

    Improvement must be seen in tender (68 assessed joints) and swollen joint counts (66 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the left end of the scale "no disease activity" [symptom-free and no arthritis symptoms], right end of the scale "maximum disease activity"); patient assessment of pain in the previous 24 hours on a VAS (left end of the scale "no pain", right end of the scale "unbearable pain"); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate.

    Measured: Baseline to Week 264

  5. Percentage of Participants Who Achieved a Major Clinical Response at Weeks 48, 96, 144, 192, and 264

    A major clinical response was defined as maintenance of an improvement of at least 70% in the American College of Rheumatology (ACR) score (ACR70) for at least 24 weeks. Improvement must be seen in tender (68 assessed joints) and swollen joint counts (66 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the left end of the scale "no disease activity" [symptom-free and no arthritis symptoms], right end of the scale "maximum disease activity"); patient assessment of pain in the previous 24 hours on a VAS (left end of the scale "no pain", right end of the scale "unbearable pain"); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate.

    Measured: Baseline to Week 264

  6. Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264

    Improvement must be seen in tender (68 assessed joints) and swollen joint counts (66 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the left end of the scale "no disease activity" [symptom-free and no arthritis symptoms], right end of the scale "maximum disease activity"); patient assessment of pain in the previous 24 hours on a VAS (left end of the scale "no pain", right end of the scale "unbearable pain"); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate.

    Measured: Baseline to Week 264

  7. Swollen and Tender Joint Count (SJC/TJC) at Baseline and Weeks 24, 48, 108, 156, 204, and 264

    The number of swollen (66 assessed joints) and tender (68 assessed joints) joints was assessed. Joints were physically examined and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation.

    Measured: Baseline to Week 264

  8. Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264

    Participant's made a global assessment of their current disease activity on a 100 mm horizontal visual analogue scale (VAS). The left end of the scale indicated "no disease activity" (symptom-free and no arthritis symptoms, score = 0) and the right end indicated "maximum disease activity" (maximum arthritis disease activity, score = 100). The participant's treating physician made a global assessment of the participant's current disease activity on a 100 mm horizontal VAS. The left end of the scale indicated "no disease activity" (symptom-free and no arthritis symptoms, score = 0) and the right end indicated "maximum disease activity" (maximum arthritis disease activity, score = 100). Participant's made an assessment of their current level of pain on a 100 mm horizontal VAS. The left end of the scale indicated "no pain" (score = 0) and the right end of the scale indicated "unbearable pain" (score = 100).

    Measured: Baseline to Week 264

  9. Health Assessment Questionnaire-Disability Index Score at Baseline and Weeks 24, 48, 108, 156, 204, and 264

    The Health Assessment Questionnaire-Disability Index (HAQ-DI), as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. To calculate the overall score, the patient must have a domain score in at least 6 of the 8 domains. The HAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A higher score indicates less ability.

    Measured: Baseline to Week 264

  10. Erythrocyte Sedimentation Rate at Baseline and Weeks 24, 48, 108, 156, 204, and 264

    Erythrocyte sedimentation rate (ESR) was determined locally.

    Measured: Baseline to Week 264

  11. Change in the Disease Activity Score 28 (DAS-28) From Baseline to Weeks 24, 48, 96, and 264

    The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement.

    Measured: Baseline to Week 264

  12. Percentage of Participants Who Were Disease Activity Score 28 (DAS-28) Responders at Weeks 24, 48, 108, 156, 204, and 264

    A DAS-28 responder was defined as someone who met the European League Against Rheumatism [EULAR] criteria of a good or moderate response. A change of the DAS-28 score from Baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.

    Measured: Baseline to Week 264

  13. Percentage of Participants Who Maintained a Disease Activity Score 28 (DAS-28) Response for 24, 48, 96, 144, and 192 Weeks at Weeks 48, 96, 144, 192, and 264

    A DAS-28 responder was defined as someone who met the European League Against Rheumatism [EULAR] criteria of a good or moderate response. A change of the DAS-28 score from Baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.

    Measured: Baseline to Week 264

  14. Percentage of Participants With a Clinically Relevant Improvement in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 24, 36, 48, 108, 156, 204, and 264

    The FACIT-F is a 13-item participant self-report questionnaire that assesses fatigue over the previous 7 days by scoring each item on a 5-point scale (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). An overall FACIT-F score was obtained by summing the scores of all 13 items. The overall score ranged from 0 to 52. A lower score indicates less fatigue. A clinically relevant improvement in the FACIT-F score was defined as a ≥ 5-point increase from Baseline.

    Measured: Baseline to Week 264

  15. Percentage of Participants With a Clinically Relevant Improvement in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Weeks 24, 48, 108, 156, 204, and 264

    The SF-36 Health Survey uses participant-reported symptoms on 8 subscales to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100 with a higher score indicating better HRQoL. A clinically relevant improvement in the Physical and Mental Component Scores of the SF-36 was defined as a ≥ 5-point increase from Baseline.

    Measured: Baseline to Week 264

Timeline

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

  1. First posted23 Jul 2008 (estimated)
  2. Study startSep 2005
  3. Primary completionApr 2013
  4. Study completionApr 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2,067 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00720798
Sponsor's protocol ID
WA18696
Status last verified
Sep 2014
First submitted
22 Jul 2008
Last updated
30 Sep 2014

Publications

  • Jones G, Wallace T, McIntosh MJ, Brockwell L, Gomez-Reino JJ, Sebba A. Five-year Efficacy and Safety of Tocilizumab Monotherapy in Patients with Rheumatoid Arthritis Who Were Methotrexate- and Biologic-naive or Free of Methotrexate for 6 Months: the AMBITION Study. J Rheumatol. 2017 Feb;44(2):142-146. doi: 10.3899/jrheum.160287. Epub 2016 Dec 1.

    PubMed 27909081

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tocilizumab, Disease-modifying anti-rheumatic drugs and Non-steroidal anti-inflammatory drugs in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 295 sites in 34 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 1 inclusion and 6 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 30 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 295 sites in United States, France, Canada, Germany, United Kingdom and 29 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 30 Sep 2014). 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 With ≥ 1 Adverse Event (time frame: Baseline to the end of the study (up to 7 years, 7 months)). 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 NCT00720798, 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 30 Sep 2014.

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