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Rheumatoid ArthritisPhase 3NCT00195702

Efficacy and Safety of Adalimumab in Patients With Active Rheumatoid Arthritis Treated Concomitantly With Methotrexate.

A Phase 3 study testing Adalimumab in people with Rheumatoid Arthritis, run by Abbott at 87 sites in 2 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

The purpose of the study was to assess the safety, immunogenicity, and clinical efficacy of adalimumab compared with placebo (during double-blind phase) and to to evaluate the long-term safety and maintenance of efficacy following repeated administration of adalimumab (during open-label extension phase) in patients… 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?
Adalimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
619 participants
Where
87 sitesin 2 countries
Study dates
Feb 2000to Aug 2010
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

  • Age 18 or older and in good health (Investigator discretion) with a recent stable medical history
  • Met American College of Rheumatology (ACR) criteria for diagnosis of active rheumatoid arthritis (RA) and had at both screening and baseline visits >=6 swollen joints and >=9 tender joints, despite a minimum of 3-months treatment with methotrexate (MTX). (Distal interphalangeal joints [DIPs] were not to be included in joint count for inclusion. The screening and baseline visits could be 3 to 28 days apart for patients not previously receiving disease-modifying anti-rheumatic drugs [DMARDs] other than MTX or 4 to 6 weeks for patients requiring a DMARD washout period.)
  • Insufficient efficacy with MTX 12.5 to 25 mg per week (10 mg per week if MTX intolerant).
  • If patient on a second-line treatment (DMARD) other than MTX, he/she had to discontinue it for at least 28 days before the baseline visit (the washout period).
  • Treatment with oral folic acid 1-3 mg/day or, if appropriate, up to 10 mg leucovorin per week.
  • Both rheumatoid factor positivity and a C-reactive protein value >=1 mg/dL, or at least one joint erosion on X-ray.

Who cannot join

  • Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study.
  • Female subject who was pregnant or breast-feeding or considering becoming pregnant.
  • Preceding treatment with any tumor necrosis factor (TNF) antagonist, including adalimumab.
  • Prior exposure to alkylating agents, such as chlorambucil or cyclophosphamide.
  • Intra-articular, intramuscular, or intravenous administration of corticosteroids within 4 weeks prior to the screening visit.
  • Subject was wheelchair bound or bedridden.

Trial locations and contacts

87 sites in 2 countries.

87 sites in 2 countries

United States76 sites

  • Site Ref # / Investigator 60736

    Anaheim, California, 92801

  • Site Ref # / Investigator 716

    Austin, Texas, 78705

  • Site Ref # / Investigator 710

    Aventura, Florida, 33180

  • Site Ref # / Investigator 392

    Baltimore, Maryland, 21239

  • Site Ref # / Investigator 2436

    Boise, Idaho, 83704

  • Site Ref # / Investigator 465

    Burlington, Massachusetts, 01805

  • Site Ref # / Investigator 718

    Charleston, South Carolina, 29406

  • Site Ref # / Investigator 60732

    Chicago, Illinois, 60611

  • Site Ref # / Investigator 60735

    Colmar, Pennsylvania, 18915-9671

  • Site Ref # / Investigator 353

    Concord, New Hampshire, 03301

  • Site Ref # / Investigator 354

    Cumberland, Maryland, 21502

  • Site Ref # / Investigator 712

    Danbury, Connecticut, 06810

  • Site Ref # / Investigator 364

    Dover, New Hampshire, 03820

  • Site Ref # / Investigator 2507

    Duncansville, Pennsylvania, 16635

  • Site Ref # / Investigator 498

    Dunedin, Florida, 34698

  • Site Ref # / Investigator 512

    Durham, North Carolina, 27704

  • Site Ref # / Investigator 717

    East Norriton, Pennsylvania, 19401

  • Site Ref # / Investigator 360

    Escondido, California, 92025

  • Site Ref # / Investigator 422

    Eugene, Oregon, 97401

  • Site Ref # / Investigator 60725

    Falls Church, Virginia, 22044

  • Site Ref # / Investigator 60728

    Galveston, Texas, 77555-0759

  • Site Ref # / Investigator 471

    Grand Rapids, Michigan, 49506

  • Site Ref # / Investigator 340

    Greensboro, North Carolina, 27408

  • Site Ref # / Investigator 2509

    Houston, Texas, 77074

  • Site Ref # / Investigator 510

    Houston, Texas, 77074

  • Site Ref # / Investigator 424

    Huntsville, Alabama, 35801

  • Site Ref # / Investigator 485

    Idaho Falls, Idaho, 83404

  • Site Ref # / Investigator 2506

    Indianapolis, Indiana, 46260

  • Site Ref # / Investigator 473

    Kalamazoo, Michigan, 49009

  • Site Ref # / Investigator 731

    Kansas City, Missouri, 64114

  • Site Ref # / Investigator 60738

    Kenosha, Wisconsin, 53142

  • Site Ref # / Investigator 714

    La Jolla, California, 92037-0943

  • Site Ref # / Investigator 469

    La Jolla, California, 92037

  • Site Ref # / Investigator 491

    Lexington, Kentucky, 40509

  • Site Ref # / Investigator 456

    Mayfield Village, Ohio, 44143

  • Site Ref # / Investigator 352

    Mechanicsburg, Pennsylvania, 17055

  • Site Ref # / Investigator 460

    Memphis, Tennessee, 38119

  • Site Ref # / Investigator 60726

    Mercerville, New Jersey, 08619

  • Site Ref # / Investigator 2510

    Mobile, Alabama, 36608

  • Site Ref # / Investigator 462

    Nashville, Tennessee, 37205

  • Site Ref # / Investigator 470

    Oklahoma City, Oklahoma, 73112

  • Site Ref # / Investigator 60723

    Oklahoma City, Oklahoma, 73112

  • Site Ref # / Investigator 487

    Omaha, Nebraska, 68114

  • Site Ref # / Investigator 499

    Orlando, Florida, 32806

  • Site Ref # / Investigator 419

    Palm Desert, California, 92260

  • Site Ref # / Investigator 60729

    Phoenix, Arizona, 85012

  • Site Ref # / Investigator 2508

    Portland, Maine, 04102

  • Site Ref # / Investigator 461

    Raleigh, North Carolina, 27609

  • Site Ref # / Investigator 500

    Raleigh, North Carolina, 27609

  • Site Ref # / Investigator 60731

    Raleigh, North Carolina, 27612

  • Site Ref # / Investigator 711

    Richmond, Virginia, 23219

  • Site Ref # / Investigator 483

    Rochester, New York, 14609

  • Site Ref # / Investigator 60737

    Salisbury, North Carolina, 28144

  • Site Ref # / Investigator 492

    San Jose, California, 95126

  • Site Ref # / Investigator 60734

    San Louis Obispo, California, 93405

  • Site Ref # / Investigator 725

    Scottsdale, Arizona, 85260

  • Site Ref # / Investigator 509

    Seattle, Washington, 98166-2967

  • Site Ref # / Investigator 60730

    Shawnee Mission, Kansas, 66216

  • Site Ref # / Investigator 732

    South Bend, Indiana, 46601

  • Site Ref # / Investigator 356

    Spokane, Washington, 99204

  • Site Ref # / Investigator 726

    Springfield, Illinois, 62704

  • Site Ref # / Investigator 502

    St Louis, Missouri, 63110

  • Site Ref # / Investigator 482

    St Louis, Missouri, 63128

  • Site Ref # / Investigator 371

    St Louis, Missouri, 63141

  • Site Ref # / Investigator 464

    Tacoma, Washington, 98405

  • Site Ref # / Investigator 729

    Tampa, Florida, 33614

  • Site Ref # / Investigator 60739

    Van Nuys, California, 91405

  • Site Ref # / Investigator 358

    Voorhees Township, New Jersey, 08043

  • Site Ref # / Investigator 480

    Wexford, Pennsylvania, 15090

  • Site Ref # / Investigator 730

    Wheaton, Maryland, 20902

  • Site Ref # / Investigator 467

    Wichita, Kansas, 67203

  • Site Ref # / Investigator 494

    Wichita, Kansas, 67208

  • Site Ref # / Investigator 2512

    Worcester, Massachusetts, 01610

  • Site Ref # / Investigator 2511

    Wyomissing, Pennsylvania, 19610

  • Site Ref # / Investigator 60724

    Wyomissing, Pennsylvania, 19610

  • Site Ref # / Investigator 463

    Zephyrhills, Florida, 33542

Other trials in United States

Canada11 sites

  • Site Ref # / Investigator 475

    Calgary, Alberta, T2N 4N1

  • Site Ref # / Investigator 496

    Halifax, Nova Scotia, B3H 4K4

  • Site Ref # / Investigator 363

    Montreal, Quebec, H3Z 2Z3

  • Site Ref # / Investigator 444

    Newmarket, Ontario, L3Y 3R7

  • Site Ref # / Investigator 495

    Penticton, British Columbia, V2A 3G8

  • Site Ref # / Investigator 2496

    Richmond, British Columbia, V7C 5L9

  • Site Ref # / Investigator 60702

    Saskatoon, Saskatchewan, S7N 0W8

  • Site Ref # / Investigator 2497

    Toronto, Ontario, M4N 3M5

  • Site Ref # / Investigator 478

    Toronto, Ontario, M5L 3L9

  • Site Ref # / Investigator 421

    Toronto, Ontario, M5T 2S8

  • Site Ref # / Investigator 2495

    Winnipeg, Manitoba, R3N OK6

Other trials in Canada

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Rheumatoid Arthritis Patients Currently Receiving Treatment With Methotrexate

The purpose of the study was to assess the safety, immunogenicity, and clinical efficacy of adalimumab compared with placebo (during double-blind phase) and to to evaluate the long-term safety and maintenance of efficacy following repeated administration of adalimumab (during open-label extension phase) in patients with persistently active rheumatoid arthritis who were receiving concurrent methotrexate therapy.

Read the detailed description

This was a 10-year study which had an initial 52-week, double-blind, placebo-controlled phase followed by an open-label extension phase up to 9 years in duration. Data were analyzed for the double-blind phase using all patients who were randomized and received at least one dose of study drug through Week 52 and for all patients who received at least one dose of adalimumab during the 10-year study (the Intent-to-Treat [ITT] population).

Being tested
Adalimumab, Placebo
Keywords
Rheumatoid Arthritis
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • AdalimumabBiological

    Also called ABT-D2E7, Humira

    Self-administered, subcutaneous injection of 20 mg adalimumab (1.6 mL/injection) once weekly (ew) for up to 52 weeks.

  • AdalimumabBiological

    Also called ABT-D2E7, Humira

    Self-administered, subcutaneous injection of 40 mg adalimumab (1.6 mL/injection) every other week (eow) for up to 52 weeks.

  • PlaceboDrug

    Self-administered, subcutaneous injection of placebo (1.6 mL/injection) once weekly (ew) for up to 52 weeks.

  • AdalimumabBiological

    Also called ABT-D2E7, Humira

    Self-administration, subcutaneous (SC) injection of adalimumab 20 mg (1.6 mL/injection) once weekly (ew) for 52 weeks, followed by self-administration, SC injection of adalimumab 40 mg (0.8 mL/injection) every other week (eow) for up to Week 520.

  • AdalimumabBiological

    Also called ABT-D2E7, Humira

    Self-administration, subcutaneous (SC) injection of adalimumab 40 mg (1.6 mL/injection) every other week (eow) (with a placebo 1.6 mL/injection on alternate weeks) for 52 weeks, followed by self-administration, SC injection of adalimumab 40 mg (0.8 mL injection) eow for up to Week 520.

  • AdalimumabBiological

    Also called ABT-D2E7, Humira

    Self-administration, subcutaneous (SC) injection of placebo solution (1.6 mL/injection) once weekly (ew) for 52 weeks, followed by self-administration, SC injection of adalimumab 40 mg (0.8 mL/injection) every other week (eow) for up to Week 520.

Study groups in NCT00195702
Study groupRoleWhat they receive
DB adalimumab 20 mg ewExperimentalSubjects received 20 mg adalimumab subcutaneously (SC) once weekly (ew) and concomitant methotrexate (MTX) during the double-blind (DB) phase.
Receives: Biological: Adalimumab
DB adalimumab 40 mg eowExperimentalSubjects received 40 mg adalimumab subcutaneously (SC) every other week (eow) and concomitant methotrexate (MTX) during the double-blind (DB) phase. Subjects received placebo injections SC and concomitant MTX on the alternate weeks during the DB phase.
Receives: Biological: Adalimumab
DB placebo ewPlacebo comparatorSubjects received placebo subcutaneously (SC) once weekly (ew) and concomitant methotrexate (MTX) during the double-blind (DB) phase.
Receives: Drug: Placebo
DB adalimumab 20 mg ew/OL adalimumab 40 mg eowExperimentalSubjects received adalimumab 20 mg subcutaneously (SC) once weekly (ew) during the double-blind (DB) phase, then adalimumab 40 mg SC every other week (eow) during the open-label (OL) extension phase, along with concomitant methotrexate (MTX).
Receives: Biological: Adalimumab
DB adalimumab 40 mg eow/OL adalimumab 40 mg eowExperimentalSubjects received adalimumab 40 mg subcutaneously (SC) every other week (eow) with placebo on alternate weeks during the double-blind (DB) phase, then adalimumab 40 mg SC eow during the open-label (OL) extension phase, along with concomitant methotrexate (MTX).
Receives: Biological: Adalimumab
DB placebo ew/OL adalimumab 40 mg eowExperimentalSubjects received placebo subcutaneously (SC) once weekly (ew) during the double-blind phase, then adalimumab 40 mg SC every other week (eow) during the open-label (OL) extension phase, along with concomitant methotrexate (MTX).
Receives: Biological: Adalimumab

What is being measured

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

  1. Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 24

    Patients were responders if they had: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.

    Measured: Week 24

  2. Change From Baseline in Modified Total Sharp X-ray Score at Week 52

    Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 52. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.

    Measured: Baseline and Week 52

  3. Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 52

    Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from baseline in the disability index of the HAQ indicated improvement.

    Measured: Baseline and Week 52

Secondary outcomes (10)

  1. Number of Participants Meeting ACR20 Response Criteria at Week 52

    Patients were responders if they had: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.

    Measured: Week 52

  2. Change From Baseline in Modified Total Sharp X-ray Score at Week 24

    Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 24. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.

    Measured: Baseline and Week 24

  3. Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 24

    Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from baseline in the disability index of the HAQ indicated improvement.

    Measured: Baseline and Week 24

  4. Maintenance of the Disability Index of the HAQ at Week 52 for Participants Who Were Responders at Week 12 or Week 24

    Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Responders had a >= 0.22-unit decrease (improvement) in HAQ scores from baseline to Week 12 or 24.

    Measured: Week 52

  5. Maintenance of ACR20 Response at Week 52 for Participants Who Were ACR20 Responders at Week 24

    Patients were responders if they had: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.

    Measured: Week 52

  6. Number of Participants With a Continuous ACR70 Response for 6 Months During 52 Weeks of Treatment

    Patients were responders if they had: >= 70% improvement in tender joint count; >= 70% improvement in swollen joint count; and >= 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.

    Measured: Baseline through Week 52

  7. Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point

    Patients were responders if they had: >= 20% improvement in tender joint count; >= 20% improvement in swollen joint count; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.

    Measured: Baseline through Week 52

  8. Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point

    Patients were responders if they had: >= 50% improvement in tender joint count; >= 50% improvement in swollen joint count; and >= 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.

    Measured: Baseline through Week 52

  9. Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point

    Patients were responders if they had: >= 70% improvement in tender joint count; >= 70% improvement in swollen joint count; and >= 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.

    Measured: Baseline through Week 52

  10. Estimated Yearly Progression of Rheumatoid Arthritis

    Estimated yearly progression was defined as modified total Sharp x-ray score at baseline divided by duration of rheumatoid arthritis disease at baseline. Actual progression during the study was defined as modified total Sharp x-ray score at Week 52 minus modified total Sharp x-ray score at baseline divided by the duration of the study. The range of scores for the modified total Sharp x-ray score was 0 (normal) to 398 (maximal disease).

    Measured: Baseline and Week 52

Timeline

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

  1. First posted20 Sep 2005 (estimated)
  2. Study startFeb 2000
  3. Primary completionSep 2002
  4. Study completionAug 2010

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
Double blind
Who is masked
Participant, Investigator
Enrolment
619 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00195702
Sponsor's protocol ID
DE019
Status last verified
Aug 2011
First submitted
13 Sep 2005
Last updated
26 Aug 2011
Data monitoring committee
Yes

Publications

  • Smolen J, Fleischmann R, Aletaha D, Li Y, Zhou Y, Sainsbury I, Galindo IL. Disease activity improvements with optimal discriminatory ability between treatment arms: applicability in early and established rheumatoid arthritis clinical trials. Arthritis Res Ther. 2019 Nov 10;21(1):231. doi: 10.1186/s13075-019-2005-9.

    PubMed 31707982

  • Keystone EC, Breedveld FC, van der Heijde D, van Vollenhoven RF, Emery P, Smolen JS, Sainsbury I, Florentinus S, Kupper H, Chen K, Kavanaugh A. Achieving comprehensive disease control in patients with early and established rheumatoid arthritis treated with adalimumab plus methotrexate versus methotrexate alone. RMD Open. 2017 Sep 26;3(2):e000445. doi: 10.1136/rmdopen-2017-000445. eCollection 2017.

    PubMed 29018564

  • Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.

    PubMed 27338778

  • Emery P, Kavanaugh A, Bao Y, Ganguli A, Mulani P. Comprehensive disease control (CDC): what does achieving CDC mean for patients with rheumatoid arthritis? Ann Rheum Dis. 2015 Dec;74(12):2165-74. doi: 10.1136/annrheumdis-2014-205302. Epub 2014 Aug 19.

    PubMed 25139667

  • Landewe R, Ostergaard M, Keystone EC, Florentinus S, Liu S, van der Heijde D. Analysis of integrated radiographic data from two long-term, open-label extension studies of adalimumab for the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken). 2015 Feb;67(2):180-6. doi: 10.1002/acr.22426.

    PubMed 25073879

  • Keystone EC, van der Heijde D, Kavanaugh A, Kupper H, Liu S, Guerette B, Mozaffarian N. Clinical, functional, and radiographic benefits of longterm adalimumab plus methotrexate: final 10-year data in longstanding rheumatoid arthritis. J Rheumatol. 2013 Sep;40(9):1487-97. doi: 10.3899/jrheum.120964. Epub 2013 Jul 1.

    PubMed 23818718

  • Keystone EC, Kavanaugh A, Weinblatt ME, Patra K, Pangan AL. Clinical consequences of delayed addition of adalimumab to methotrexate therapy over 5 years in patients with rheumatoid arthritis. J Rheumatol. 2011 May;38(5):855-62. doi: 10.3899/jrheum.100752. Epub 2011 Feb 1.

    PubMed 21285171

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adalimumab in people with Rheumatoid Arthritis, run by Abbott at 87 sites in 2 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 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 26 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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 1 Mar 2010). 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 Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 24 (time frame: Week 24). The study lists 3 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 NCT00195702, which also lists 7 linked publications.

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 26 Aug 2011.

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