Long Term Open Label Continuation Study

NCT00195650 | Completed Phase 3 Results

• 1 other identifier: DE020
• Study Type: interventional
• Target: 846
• Locations: 2 countries
• Sites: 92

Brief Summary

The purpose of the study was to assess the long-term safety and clinical efficacy following repeated administration of adalimumab in patients with rheumatoid arthritis.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (10)

• Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 520

  ACR20 response criteria were: \>=20% improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of the 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 C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.

  Week 520

• Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 260

  ACR20 response criteria were: \>=20% improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of the 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 C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.

  Week 260

• Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 520

  ACR50 response criteria were: \>=50% improvement in tender joint count; \>=50% improvement in swollen joint count; and \>=50% improvement in at least 3 of the 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 C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.

  Week 520

• Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 260

  ACR50 response criteria were: \>=50% improvement in tender joint count; \>=50% improvement in swollen joint count; and \>=50% improvement in at least 3 of the 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 C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.

  Week 260

• Number of Participants Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 520

  ACR70 response criteria were: \>=70% improvement in tender joint count; \>=70% improvement in swollen joint count; and \>=70% improvement in at least 3 of the 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 C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.

  Week 520

• Number of Participants Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 260

  ACR70 response criteria were: \>=70% improvement in tender joint count; \>=70% improvement in swollen joint count; and \>=70% improvement in at least 3 of the 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 C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.

  Week 260

• Number of Participants in Clinical Remission (Based on Modified Disease Activity Score) at Week 520

  Clinical remission on modified Disease Activity Score (DAS28) was a value \<2.6; \>=2.6 to \<=3.2 indicated low disease activity; \>3.2 to \<=5.1 indicated moderate disease activity; and \>5.1 indicated high disease activity. DAS28 score is calculated using the number of tender joints and swollen joints (out of 28 each), patient global assessment of disease activity, and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response).

  Week 520

• Number of Participants in Clinical Remission (Based on Modified Disease Activity Score) at Week 260

  Clinical remission on modified Disease Activity Score (DAS28) was a value \<2.6; \>=2.6 to \<=3.2 indicated low disease activity; \>3.2 to \<=5.1 indicated moderate disease activity; and \>5.1 indicated high disease activity. DAS28 score is calculated using the number of tender joints and swollen joints (out of 28 each), patient global assessment of disease activity, and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response).

  Week 260

• Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 520

  The HAQ-DI is a measure of disability that ranges from 0 to 3. Decrease in score indicates improvement in physical function; a decrease of 0.22 or greater from Baseline score is clinically significant. Participants assessed their ability to perform at least 6 of the following 8 specific tasks (1. dress/groom; 2. arise; 3. eat; 4. walk; 5. reach; 6. grip; 7. maintain hygiene; 8. maintain daily activity) 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). The 8 task scores are added and the sum is divided by the number of tasks assessed (range = 6 to 8). This yields a HAQ-DI score of 0 to 3.

  Baseline of prior Phase 1, 2, or 3 adalimumab study and Week 520

• Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 260

  The HAQ-DI is a measure of disability that ranges from 0 to 3. Decrease in score indicates improvement in physical function; a decrease of 0.22 or greater from Baseline score is clinically significant. Participants assessed their ability to perform at least 6 of the following 8 specific tasks (1. dress/groom; 2. arise; 3. eat; 4. walk; 5. reach; 6. grip; 7. maintain hygiene; 8. maintain daily activity) 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). The 8 task scores are added and the sum is divided by the number of tasks assessed (range = 6 to 8). This yields a HAQ-DI score of 0 to 3.

  Baseline of prior Phase 1, 2, or 3 adalimumab study and Week 260

Secondary Outcomes (1)

• Reported Adverse Events

  Duration of study (up to 520 weeks [10 years])

Study Arms (1)

Adalimumab

EXPERIMENTAL

Open-label adalimumab 40 mg

Biological: Adalimumab

Interventions

Adalimumab BIOLOGICAL

Subcutaneous injection of 40 mg adalimumab every other week (eow) or monthly for up to 520 weeks (10 years)

Also known as: Humira, ABT-D2E7

Adalimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant was in a prior D2E7 (adalimumab) study
• Participant was age 18 or older and in good health (Investigator discretion) with a recent stable medical history.

You may not qualify if:

• Participant was considered by the investigator, for any reason, to be an unsuitable candidate for the study
• Participant was a female subject who is pregnant or breast-feeding or considering becoming pregnant
• Participant had any ongoing chronic or active infection

Sponsors & Collaborators

• Abbott: lead

Study Sites (92)

Site Reference ID/Investigator# 538

Birmingham, Alabama, 35205, United States

Location

Site Reference ID/Investigator# 4111

Birmingham, Alabama, 35294-7201, United States

Location

Site Reference ID/Investigator# 4113

Mobile, Alabama, 36608, United States

Location

Site Reference ID/Investigator# 408

Anchorage, Alaska, 99508, United States

Location

Site Reference ID/Investigator# 537

Tucson, Arizona, 85710, United States

Location

Site Reference ID/Investigator# 66822

Anaheim, California, 92801, United States

Location

Site Reference ID/Investigator# 557

La Jolla, California, 92037-0943, United States

Location

Site Reference ID/Investigator# 387

Los Angeles, California, 90048, United States

Location

Site Reference ID/Investigator# 555

Los Angeles, California, 90095, United States

Location

Site Reference ID/Investigator# 552

Santa Barbara, California, 93105, United States

Location

Site Reference ID/Investigator# 66864

Santa Monica, California, 90404, United States

Location

Site Reference ID/Investigator# 535

Stanford, California, 94305, United States

Location

Site Reference ID/Investigator# 3412

Upland, California, 91786, United States

Location

Site Reference ID/Investigator# 451

Westlake Village, California, 91361, United States

Location

Site Reference ID/Investigator# 572

Colorado Springs, Colorado, 80910, United States

Location

Site Reference ID/Investigator# 4109

Denver, Colorado, 80230, United States

Location

Site Reference ID/Investigator# 541

Danbury, Connecticut, 06810, United States

Location

Site Reference ID/Investigator# 654

Milford, Connecticut, 06460, United States

Location

Site Reference ID/Investigator# 655

Wilmington, Delaware, 19808, United States

Location

Site Reference ID/Investigator# 455

Daytona Beach, Florida, 32114, United States

Location

Site Reference ID/Investigator# 431

Fort Lauderdale, Florida, 33334, United States

Location

Site Reference ID/Investigator# 574

Fort Myers, Florida, 33901, United States

Location

Site Reference ID/Investigator# 66843

Gainesville, Florida, 32605, United States

Location

Site Reference ID/Investigator# 579

Orlando, Florida, 32804, United States

Location

Site Reference ID/Investigator# 571

Palm Harbor, Florida, 34684, United States

Location

Site Reference ID/Investigator# 651

Sarasota, Florida, 34239, United States

Location

Site Reference ID/Investigator# 66863

St. Petersburg, Florida, 33710, United States

Location

Site Reference ID/Investigator# 542

Tampa, Florida, 33609, United States

Location

Site Reference ID/Investigator# 415

Vero Beach, Florida, 32962, United States

Location

Site Reference ID/Investigator# 652

Zephyrhills, Florida, 33542, United States

Location

Site Reference ID/Investigator# 449

Boise, Idaho, 83702, United States

Location

Site Reference ID/Investigator# 4110

Boise, Idaho, 83706, United States

Location

Site Reference ID/Investigator# 650

Coeur d'Alene, Idaho, 83814, United States

Location

Site Reference ID/Investigator# 578

Chicago, Illinois, 60612, United States

Location

Site Reference ID/Investigator# 4112

Indianapolis, Indiana, 46260, United States

Location

Site Reference ID/Investigator# 547

Louisville, Kentucky, 40291, United States

Location

Site Reference ID/Investigator# 534

Metairie, Louisiana, 70006, United States

Location

Site Reference ID/Investigator# 544

Chevy Chase, Maryland, 20815, United States

Location

Site Reference ID/Investigator# 653

Boston, Massachusetts, 02115, United States

Location

Site Reference ID/Investigator# 4114

Worcester, Massachusetts, 01610, United States

Location

Site Reference ID/Investigator# 546

Petoskey, Michigan, 49770, United States

Location

Site Reference ID/Investigator# 577

St Louis, Missouri, 63128, United States

Location

Site Reference ID/Investigator# 549

Billings, Montana, 59101, United States

Location

Site Reference ID/Investigator# 561

Reno, Nevada, 89502, United States

Location

Site Reference ID/Investigator# 573

Dover, New Jersey, 07801, United States

Location

Site Reference ID/Investigator# 66842

Toms River, New Jersey, 08755, United States

Location

Site Reference ID/Investigator# 559

Voorhees Township, New Jersey, 08043, United States

Location

Site Reference ID/Investigator# 562

Albuquerque, New Mexico, 87102, United States

Location

Site Reference ID/Investigator# 66823

Brooklyn, New York, 11203, United States

Location

Site Reference ID/Investigator# 432

Lake Success, New York, 11042, United States

Location

Site Reference ID/Investigator# 657

New York, New York, 10003, United States

Location

Site Reference ID/Investigator# 647

New York, New York, 10021, United States

Location

Site Reference ID/Investigator# 545

Port Jefferson Station, New York, 11776, United States

Location

Site Reference ID/Investigator# 540

Syracuse, New York, 13210, United States

Location

Site Reference ID/Investigator# 646

Statesville, North Carolina, 28625, United States

Location

Site Reference ID/Investigator# 438

Cincinnati, Ohio, 45219, United States

Location

Site Reference ID/Investigator# 436

Dayton, Ohio, 45408, United States

Location

Site Reference ID/Investigator# 548

Bend, Oregon, 97701, United States

Location

Site Reference ID/Investigator# 553

Eugene, Oregon, 97401, United States

Location

Site Reference ID/Investigator# 532

Portland, Oregon, 97205, United States

Location

Site Reference ID/Investigator# 570

Bethlehem, Pennsylvania, 18015, United States

Location

Site Reference ID/Investigator# 575

Ridley Park, Pennsylvania, 19078-2210, United States

Location

Site Reference ID/Investigator# 585

Willow Grove, Pennsylvania, 19090, United States

Location

Site Reference ID/Investigator# 2435

Dallas, Texas, 75231, United States

Location

Site Reference ID/Investigator# 536

Richmond, Virginia, 23219, United States

Location

Site Reference ID/Investigator# 649

Everett, Washington, 98201, United States

Location

Site Reference ID/Investigator# 66862

Everett, Washington, 98201, United States

Location

Site Reference ID/Investigator# 531

Kirkland, Washington, 98034, United States

Location

Site Reference ID/Investigator# 412

Olympia, Washington, 98502, United States

Location

Site Reference ID/Investigator# 658

Spokane, Washington, 99204, United States

Location

Site Reference ID/Investigator# 576

Vancouver, Washington, 98664, United States

Location

Site Reference ID/Investigator# 551

Yakima, Washington, 98902, United States

Location

Site Reference ID/Investigator# 656

Glendale, Wisconsin, 53217, United States

Location

Site Reference ID/Investigator# 539

Milwaukee, Wisconsin, 53215, United States

Location

Site Reference ID/Investigator# 513

Calgary, T2V 1P9, Canada

Location

Site Reference ID/Investigator# 568

Charlottetown, C1A 5Y8, Canada

Location

Site Reference ID/Investigator# 565

Hamilton, L8N 1Y2, Canada

Location

Site Reference ID/Investigator# 564

Hamilton, L8N 2B6, Canada

Location

Site Reference ID/Investigator# 569

Kitchener, N2M 5N6, Canada

Location

Site Reference ID/Investigator# 3440

Montreal, H2L 1S6, Canada

Location

Site Reference ID/Investigator# 413

Montreal, H3Z 2Z3, Canada

Location

Site Reference ID/Investigator# 66805

North York, M3H 5Y8, Canada

Location

Site Reference ID/Investigator# 66807

North York, M3H 5Y8, Canada

Location

Site Reference ID/Investigator# 414

Ottawa, K1H 7W9, Canada

Location

Site Reference ID/Investigator# 566

Pointe-Claire, H9J 3W3, Canada

Location

Site Reference ID/Investigator# 2467

Sainte-Foy, Quebec, G1W 4R4, Canada

Location

Site Reference ID/Investigator# 66804

Scarborough, M1B 4Y9, Canada

Location

Site Reference ID/Investigator# 563

St. John's, A1B 3E1, Canada

Location

Site Reference ID/Investigator# 2466

Toronto, M4N 3M5, Canada

Location

Site Reference ID/Investigator# 567

Toronto, M5L 3L9, Canada

Location

Site Reference ID/Investigator# 3442

Vancouver, V5Z 1L7, Canada

Location

Site Reference ID/Investigator# 514

Winnipeg, R3A 1M4, Canada

Location

Related Publications (1)

• Furst DE, Kavanaugh A, Florentinus S, Kupper H, Karunaratne M, Birbara CA. Final 10-year effectiveness and safety results from study DE020: adalimumab treatment in patients with rheumatoid arthritis and an inadequate response to standard therapy. Rheumatology (Oxford). 2015 Dec;54(12):2188-97. doi: 10.1093/rheumatology/kev249. Epub 2015 Jul 21.

  PMID: 26199453 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbott

800-633-9110

Study Officials

• Hartmut Kupper, MD

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: July 1, 2000
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: August 31, 2012
• Results First Posted: July 31, 2012

Record last verified: 2012-08

Locations

US (74); CA (18)