Clinical trial NCT00195650: Long Term Open Label Continuation Study
Official title: A Multi-Center Continuation Study of the Human Anti-TNF Antibody D2E7 Administered as a Subcutaneous Injection in Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 846
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Study DE020 was a multicenter, open-label continuation study for patients with rheumatoid arthritis who had participated in a prior Phase 1, 2, or 3 adalimumab study in the United States or Canada, had a favorable safety and efficacy profile when treated with adalimumab, and met the eligibility criteria for the continuation study. Participants received subcutaneous injections of adalimumab every other week (eow) or monthly based on the adalimumab regimen received in the prior study (i.e., participants who received monthly dosing in the prior study began the continuation study on monthly dosing; all other participants began adalimumab dosing at eow intervals). Participants who maintained an American College of Rheumatology 50% (ACR50) response for 2 consecutive visits could have their dosing interval lengthened to a monthly dosing schedule. Safety and efficacy data were collected over 520 weeks (10 years). Both safety and efficacy data were analyzed using all participants who received at least 1 dose of open-label adalimumab in the 10-year continuation study DE020 (the Full Analysis Set, n=846). Three patients who entered the continuation study but were never dosed were excluded from all analyses.

Eligibility criteria: Inclusion Criteria

* 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.

Exclusion Criteria

* 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

Primary outcomes:
measure: Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 520
timeFrame: Week 520
measure: Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 260
timeFrame: Week 260
measure: Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 520
timeFrame: Week 520
measure: Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 260
timeFrame: Week 260
measure: Number of Participants Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 520
timeFrame: Week 520
measure: Number of Participants Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 260
timeFrame: Week 260
measure: Number of Participants in Clinical Remission (Based on Modified Disease Activity Score) at Week 520
timeFrame: Week 520
measure: Number of Participants in Clinical Remission (Based on Modified Disease Activity Score) at Week 260
timeFrame: Week 260
measure: Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 520
timeFrame: Baseline of prior Phase 1, 2, or 3 adalimumab study and Week 520
measure: Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 260
timeFrame: Baseline of prior Phase 1, 2, or 3 adalimumab study and Week 260
Secondary outcomes:
measure: Reported Adverse Events
timeFrame: Duration of study (up to 520 weeks [10 years])
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site Reference ID/Investigator# 538
state: Alabama
city: Birmingham
country: United States
facility: Site Reference ID/Investigator# 4111
state: Alabama
city: Mobile
country: United States
facility: Site Reference ID/Investigator# 4113
state: Alabama
city: Anchorage
country: United States
facility: Site Reference ID/Investigator# 408
state: Alaska
city: Tucson
country: United States
facility: Site Reference ID/Investigator# 537
state: Arizona
city: Anaheim
country: United States
facility: Site Reference ID/Investigator# 66822
state: California
city: La Jolla
country: United States
facility: Site Reference ID/Investigator# 557
state: California
city: Los Angeles
country: United States
facility: Site Reference ID/Investigator# 387
state: California
city: Los Angeles
country: United States
facility: Site Reference ID/Investigator# 555
state: California
city: Santa Barbara
country: United States
facility: Site Reference ID/Investigator# 552
state: California
city: Santa Monica
country: United States
facility: Site Reference ID/Investigator# 66864
state: California
city: Stanford
country: United States
facility: Site Reference ID/Investigator# 535
state: California
city: Upland
country: United States
facility: Site Reference ID/Investigator# 3412
state: California
city: Westlake Village
country: United States
facility: Site Reference ID/Investigator# 451
state: California
city: Colorado Springs
country: United States
facility: Site Reference ID/Investigator# 572
state: Colorado
city: Denver
country: United States
facility: Site Reference ID/Investigator# 4109
state: Colorado
city: Danbury
country: United States
facility: Site Reference ID/Investigator# 541
state: Connecticut
city: Milford
country: United States
facility: Site Reference ID/Investigator# 654
state: Connecticut
city: Wilmington
country: United States
facility: Site Reference ID/Investigator# 655
state: Delaware
city: Daytona Beach
country: United States
facility: Site Reference ID/Investigator# 455
state: Florida
city: Fort Lauderdale
country: United States
facility: Site Reference ID/Investigator# 431
state: Florida
city: Fort Myers
country: United States
facility: Site Reference ID/Investigator# 574
state: Florida
city: Gainesville
country: United States
facility: Site Reference ID/Investigator# 66843
state: Florida
city: Orlando
country: United States
facility: Site Reference ID/Investigator# 579
state: Florida
city: Palm Harbor
country: United States
facility: Site Reference ID/Investigator# 571
state: Florida
city: Sarasota
country: United States
facility: Site Reference ID/Investigator# 651
state: Florida
city: St. Petersburg
country: United States
facility: Site Reference ID/Investigator# 66863
state: Florida
city: Tampa
country: United States
facility: Site Reference ID/Investigator# 542
state: Florida
city: Vero Beach
country: United States
facility: Site Reference ID/Investigator# 415
state: Florida
city: Zephyrhills
country: United States
facility: Site Reference ID/Investigator# 652
state: Florida
city: Boise
country: United States
facility: Site Reference ID/Investigator# 449
state: Idaho
city: Boise
country: United States
facility: Site Reference ID/Investigator# 4110
state: Idaho
city: Coeur D'Alene
country: United States
facility: Site Reference ID/Investigator# 650
state: Idaho
city: Chicago
country: United States
facility: Site Reference ID/Investigator# 578
state: Illinois
city: Indianapolis
country: United States
facility: Site Reference ID/Investigator# 4112
state: Indiana
city: Louisville
country: United States
facility: Site Reference ID/Investigator# 547
state: Kentucky
city: Metairie
country: United States
facility: Site Reference ID/Investigator# 534
state: Louisiana
city: Chevy Chase
country: United States
facility: Site Reference ID/Investigator# 544
state: Maryland
city: Boston
country: United States
facility: Site Reference ID/Investigator# 653
state: Massachusetts
city: Worcester
country: United States
facility: Site Reference ID/Investigator# 4114
state: Massachusetts
city: Petoskey
country: United States
facility: Site Reference ID/Investigator# 546
state: Michigan
city: St. Louis
country: United States
facility: Site Reference ID/Investigator# 577
state: Missouri
city: Billings
country: United States
facility: Site Reference ID/Investigator# 549
state: Montana
city: Reno
country: United States
facility: Site Reference ID/Investigator# 561
state: Nevada
city: Dover
country: United States
facility: Site Reference ID/Investigator# 573
state: New Jersey
city: Toms River
country: United States
facility: Site Reference ID/Investigator# 66842
state: New Jersey
city: Voorhees
country: United States
facility: Site Reference ID/Investigator# 559
state: New Jersey
city: Albuquerque
country: United States
facility: Site Reference ID/Investigator# 562
state: New Mexico
city: Brooklyn
country: United States
facility: Site Reference ID/Investigator# 66823
state: New York
city: Lake Success
country: United States
facility: Site Reference ID/Investigator# 432
state: New York
city: New York
country: United States
facility: Site Reference ID/Investigator# 657
state: New York
city: New York
country: United States
facility: Site Reference ID/Investigator# 647
state: New York
city: Port Jefferson Station
country: United States
facility: Site Reference ID/Investigator# 545
state: New York
city: Syracuse
country: United States
facility: Site Reference ID/Investigator# 540
state: New York
city: Statesville
country: United States
facility: Site Reference ID/Investigator# 646
state: North Carolina
city: Cincinnati
country: United States
facility: Site Reference ID/Investigator# 438
state: Ohio
city: Dayton
country: United States
facility: Site Reference ID/Investigator# 436
state: Ohio
city: Bend
country: United States
facility: Site Reference ID/Investigator# 548
state: Oregon
city: Eugene
country: United States
facility: Site Reference ID/Investigator# 553
state: Oregon
city: Portland
country: United States
facility: Site Reference ID/Investigator# 532
state: Oregon
city: Bethlehem
country: United States
facility: Site Reference ID/Investigator# 570
state: Pennsylvania
city: Ridley Park
country: United States
facility: Site Reference ID/Investigator# 575
state: Pennsylvania
city: Willow Grove
country: United States
facility: Site Reference ID/Investigator# 585
state: Pennsylvania
city: Dallas
country: United States
facility: Site Reference ID/Investigator# 2435
state: Texas
city: Richmond
country: United States
facility: Site Reference ID/Investigator# 536
state: Virginia
city: Everett
country: United States
facility: Site Reference ID/Investigator# 649
state: Washington
city: Everett
country: United States
facility: Site Reference ID/Investigator# 66862
state: Washington
city: Kirkland
country: United States
facility: Site Reference ID/Investigator# 531
state: Washington
city: Olympia
country: United States
facility: Site Reference ID/Investigator# 412
state: Washington
city: Spokane
country: United States
facility: Site Reference ID/Investigator# 658
state: Washington
city: Vancouver
country: United States
facility: Site Reference ID/Investigator# 576
state: Washington
city: Yakima
country: United States
facility: Site Reference ID/Investigator# 551
state: Washington
city: Glendale
country: United States
facility: Site Reference ID/Investigator# 656
state: Wisconsin
city: Milwaukee
country: United States
facility: Site Reference ID/Investigator# 539
state: Wisconsin
city: Calgary
country: Canada
facility: Site Reference ID/Investigator# 513
city: Charlottetown
country: Canada
facility: Site Reference ID/Investigator# 568
city: Hamilton
country: Canada
facility: Site Reference ID/Investigator# 565
city: Hamilton
country: Canada
facility: Site Reference ID/Investigator# 564
city: Kitchener
country: Canada
facility: Site Reference ID/Investigator# 569
city: Montreal
country: Canada
facility: Site Reference ID/Investigator# 3440
city: Montreal
country: Canada
facility: Site Reference ID/Investigator# 413
city: North York
country: Canada
facility: Site Reference ID/Investigator# 66805
city: North York
country: Canada
facility: Site Reference ID/Investigator# 66807
city: Ottawa
country: Canada
facility: Site Reference ID/Investigator# 414
city: Pointe-Claire
country: Canada
facility: Site Reference ID/Investigator# 566
city: Sainte-Foy, Quebec
country: Canada
facility: Site Reference ID/Investigator# 2467
city: Scarborough
country: Canada
facility: Site Reference ID/Investigator# 66804
city: St. John's
country: Canada
facility: Site Reference ID/Investigator# 563
city: Toronto
country: Canada
facility: Site Reference ID/Investigator# 2466
city: Toronto
country: Canada
facility: Site Reference ID/Investigator# 567
city: Vancouver
country: Canada
facility: Site Reference ID/Investigator# 3442
city: Winnipeg
country: Canada
facility: Site Reference ID/Investigator# 514
Study officials:
affiliation: Abbott
name: Hartmut Kupper, MD
role: STUDY_DIRECTOR
References:
citation: 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.