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Long Term Open Label Continuation Study

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Adalimumab
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site Reference ID/Investigator# 538
  • Site Reference ID/Investigator# 4111
  • Site Reference ID/Investigator# 4113
  • Site Reference ID/Investigator# 408
  • Site Reference ID/Investigator# 537
  • Site Reference ID/Investigator# 66822
  • Site Reference ID/Investigator# 557
  • Site Reference ID/Investigator# 387
  • Site Reference ID/Investigator# 555
  • Site Reference ID/Investigator# 552
  • Site Reference ID/Investigator# 66864
  • Site Reference ID/Investigator# 535
  • Site Reference ID/Investigator# 3412
  • Site Reference ID/Investigator# 451
  • Site Reference ID/Investigator# 572
  • Site Reference ID/Investigator# 4109
  • Site Reference ID/Investigator# 541
  • Site Reference ID/Investigator# 654
  • Site Reference ID/Investigator# 655
  • Site Reference ID/Investigator# 455
  • Site Reference ID/Investigator# 431
  • Site Reference ID/Investigator# 574
  • Site Reference ID/Investigator# 66843
  • Site Reference ID/Investigator# 579
  • Site Reference ID/Investigator# 571
  • Site Reference ID/Investigator# 651
  • Site Reference ID/Investigator# 66863
  • Site Reference ID/Investigator# 542
  • Site Reference ID/Investigator# 415
  • Site Reference ID/Investigator# 652
  • Site Reference ID/Investigator# 449
  • Site Reference ID/Investigator# 4110
  • Site Reference ID/Investigator# 650
  • Site Reference ID/Investigator# 578
  • Site Reference ID/Investigator# 4112
  • Site Reference ID/Investigator# 547
  • Site Reference ID/Investigator# 534
  • Site Reference ID/Investigator# 544
  • Site Reference ID/Investigator# 653
  • Site Reference ID/Investigator# 4114
  • Site Reference ID/Investigator# 546
  • Site Reference ID/Investigator# 577
  • Site Reference ID/Investigator# 549
  • Site Reference ID/Investigator# 561
  • Site Reference ID/Investigator# 573
  • Site Reference ID/Investigator# 66842
  • Site Reference ID/Investigator# 559
  • Site Reference ID/Investigator# 562
  • Site Reference ID/Investigator# 66823
  • Site Reference ID/Investigator# 432
  • Site Reference ID/Investigator# 657
  • Site Reference ID/Investigator# 647
  • Site Reference ID/Investigator# 545
  • Site Reference ID/Investigator# 540
  • Site Reference ID/Investigator# 646
  • Site Reference ID/Investigator# 438
  • Site Reference ID/Investigator# 436
  • Site Reference ID/Investigator# 548
  • Site Reference ID/Investigator# 553
  • Site Reference ID/Investigator# 532
  • Site Reference ID/Investigator# 570
  • Site Reference ID/Investigator# 575
  • Site Reference ID/Investigator# 585
  • Site Reference ID/Investigator# 2435
  • Site Reference ID/Investigator# 536
  • Site Reference ID/Investigator# 649
  • Site Reference ID/Investigator# 66862
  • Site Reference ID/Investigator# 531
  • Site Reference ID/Investigator# 412
  • Site Reference ID/Investigator# 658
  • Site Reference ID/Investigator# 576
  • Site Reference ID/Investigator# 551
  • Site Reference ID/Investigator# 656
  • Site Reference ID/Investigator# 539
  • Site Reference ID/Investigator# 513
  • Site Reference ID/Investigator# 568
  • Site Reference ID/Investigator# 565
  • Site Reference ID/Investigator# 564
  • Site Reference ID/Investigator# 569
  • Site Reference ID/Investigator# 3440
  • Site Reference ID/Investigator# 413
  • Site Reference ID/Investigator# 66805
  • Site Reference ID/Investigator# 66807
  • Site Reference ID/Investigator# 414
  • Site Reference ID/Investigator# 566
  • Site Reference ID/Investigator# 2467
  • Site Reference ID/Investigator# 66804
  • Site Reference ID/Investigator# 563
  • Site Reference ID/Investigator# 2466
  • Site Reference ID/Investigator# 567
  • Site Reference ID/Investigator# 3442
  • Site Reference ID/Investigator# 514

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adalimumab

Arm Description

Open-label adalimumab 40 mg

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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).
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).
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.
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.

Secondary Outcome Measures

Reported Adverse Events
Adverse events were collected during the course of the study (after the first adalimumab injection in this continuation study DE020 through 70 days after the last adalimumab injection) for all participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set). The number of participants experiencing any adverse event (serious and non-serious) are summarized. See the Reported Adverse Events section for details.

Full Information

First Posted
September 13, 2005
Last Updated
August 24, 2012
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00195650
Brief Title
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

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
846 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adalimumab
Arm Type
Experimental
Arm Description
Open-label adalimumab 40 mg
Intervention Type
Biological
Intervention Name(s)
Adalimumab
Other Intervention Name(s)
Humira, ABT-D2E7
Intervention Description
Subcutaneous injection of 40 mg adalimumab every other week (eow) or monthly for up to 520 weeks (10 years)
Primary Outcome Measure Information:
Title
Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 520
Description
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.
Time Frame
Week 520
Title
Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 260
Description
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.
Time Frame
Week 260
Title
Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 520
Description
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.
Time Frame
Week 520
Title
Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 260
Description
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.
Time Frame
Week 260
Title
Number of Participants Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 520
Description
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.
Time Frame
Week 520
Title
Number of Participants Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 260
Description
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.
Time Frame
Week 260
Title
Number of Participants in Clinical Remission (Based on Modified Disease Activity Score) at Week 520
Description
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).
Time Frame
Week 520
Title
Number of Participants in Clinical Remission (Based on Modified Disease Activity Score) at Week 260
Description
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).
Time Frame
Week 260
Title
Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 520
Description
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.
Time Frame
Baseline of prior Phase 1, 2, or 3 adalimumab study and Week 520
Title
Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 260
Description
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.
Time Frame
Baseline of prior Phase 1, 2, or 3 adalimumab study and Week 260
Secondary Outcome Measure Information:
Title
Reported Adverse Events
Description
Adverse events were collected during the course of the study (after the first adalimumab injection in this continuation study DE020 through 70 days after the last adalimumab injection) for all participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set). The number of participants experiencing any adverse event (serious and non-serious) are summarized. See the Reported Adverse Events section for details.
Time Frame
Duration of study (up to 520 weeks [10 years])

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hartmut Kupper, MD
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 538
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Site Reference ID/Investigator# 4111
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-7201
Country
United States
Facility Name
Site Reference ID/Investigator# 4113
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Site Reference ID/Investigator# 408
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Site Reference ID/Investigator# 537
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Site Reference ID/Investigator# 66822
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Site Reference ID/Investigator# 557
City
La Jolla
State/Province
California
ZIP/Postal Code
92037-0943
Country
United States
Facility Name
Site Reference ID/Investigator# 387
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Site Reference ID/Investigator# 555
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Site Reference ID/Investigator# 552
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Site Reference ID/Investigator# 66864
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Site Reference ID/Investigator# 535
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Site Reference ID/Investigator# 3412
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Site Reference ID/Investigator# 451
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
Facility Name
Site Reference ID/Investigator# 572
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
Facility Name
Site Reference ID/Investigator# 4109
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Site Reference ID/Investigator# 541
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Site Reference ID/Investigator# 654
City
Milford
State/Province
Connecticut
ZIP/Postal Code
06460
Country
United States
Facility Name
Site Reference ID/Investigator# 655
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19808
Country
United States
Facility Name
Site Reference ID/Investigator# 455
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
Site Reference ID/Investigator# 431
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Site Reference ID/Investigator# 574
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Site Reference ID/Investigator# 66843
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Site Reference ID/Investigator# 579
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Site Reference ID/Investigator# 571
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Site Reference ID/Investigator# 651
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Site Reference ID/Investigator# 66863
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
Facility Name
Site Reference ID/Investigator# 542
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Site Reference ID/Investigator# 415
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32962
Country
United States
Facility Name
Site Reference ID/Investigator# 652
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Facility Name
Site Reference ID/Investigator# 449
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Site Reference ID/Investigator# 4110
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
Site Reference ID/Investigator# 650
City
Coeur D'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Site Reference ID/Investigator# 578
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Site Reference ID/Investigator# 4112
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Site Reference ID/Investigator# 547
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40291
Country
United States
Facility Name
Site Reference ID/Investigator# 534
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Site Reference ID/Investigator# 544
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Site Reference ID/Investigator# 653
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Site Reference ID/Investigator# 4114
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01610
Country
United States
Facility Name
Site Reference ID/Investigator# 546
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
Site Reference ID/Investigator# 577
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Site Reference ID/Investigator# 549
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Site Reference ID/Investigator# 561
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Site Reference ID/Investigator# 573
City
Dover
State/Province
New Jersey
ZIP/Postal Code
07801
Country
United States
Facility Name
Site Reference ID/Investigator# 66842
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Site Reference ID/Investigator# 559
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Site Reference ID/Investigator# 562
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Site Reference ID/Investigator# 66823
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Site Reference ID/Investigator# 432
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Site Reference ID/Investigator# 657
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Site Reference ID/Investigator# 647
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Site Reference ID/Investigator# 545
City
Port Jefferson Station
State/Province
New York
ZIP/Postal Code
11776
Country
United States
Facility Name
Site Reference ID/Investigator# 540
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Site Reference ID/Investigator# 646
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28625
Country
United States
Facility Name
Site Reference ID/Investigator# 438
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Site Reference ID/Investigator# 436
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45408
Country
United States
Facility Name
Site Reference ID/Investigator# 548
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Site Reference ID/Investigator# 553
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Site Reference ID/Investigator# 532
City
Portland
State/Province
Oregon
ZIP/Postal Code
97205
Country
United States
Facility Name
Site Reference ID/Investigator# 570
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Site Reference ID/Investigator# 575
City
Ridley Park
State/Province
Pennsylvania
ZIP/Postal Code
19078-2210
Country
United States
Facility Name
Site Reference ID/Investigator# 585
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
Site Reference ID/Investigator# 2435
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Site Reference ID/Investigator# 536
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Site Reference ID/Investigator# 649
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Site Reference ID/Investigator# 66862
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Site Reference ID/Investigator# 531
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
Site Reference ID/Investigator# 412
City
Olympia
State/Province
Washington
ZIP/Postal Code
98502
Country
United States
Facility Name
Site Reference ID/Investigator# 658
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Site Reference ID/Investigator# 576
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Facility Name
Site Reference ID/Investigator# 551
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
Facility Name
Site Reference ID/Investigator# 656
City
Glendale
State/Province
Wisconsin
ZIP/Postal Code
53217
Country
United States
Facility Name
Site Reference ID/Investigator# 539
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Site Reference ID/Investigator# 513
City
Calgary
ZIP/Postal Code
T2V 1P9
Country
Canada
Facility Name
Site Reference ID/Investigator# 568
City
Charlottetown
ZIP/Postal Code
C1A 5Y8
Country
Canada
Facility Name
Site Reference ID/Investigator# 565
City
Hamilton
ZIP/Postal Code
L8N 1Y2
Country
Canada
Facility Name
Site Reference ID/Investigator# 564
City
Hamilton
ZIP/Postal Code
L8N 2B6
Country
Canada
Facility Name
Site Reference ID/Investigator# 569
City
Kitchener
ZIP/Postal Code
N2M 5N6
Country
Canada
Facility Name
Site Reference ID/Investigator# 3440
City
Montreal
ZIP/Postal Code
H2L 1S6
Country
Canada
Facility Name
Site Reference ID/Investigator# 413
City
Montreal
ZIP/Postal Code
H3Z 2Z3
Country
Canada
Facility Name
Site Reference ID/Investigator# 66805
City
North York
ZIP/Postal Code
M3H 5Y8
Country
Canada
Facility Name
Site Reference ID/Investigator# 66807
City
North York
ZIP/Postal Code
M3H 5Y8
Country
Canada
Facility Name
Site Reference ID/Investigator# 414
City
Ottawa
ZIP/Postal Code
K1H 7W9
Country
Canada
Facility Name
Site Reference ID/Investigator# 566
City
Pointe-Claire
ZIP/Postal Code
H9J 3W3
Country
Canada
Facility Name
Site Reference ID/Investigator# 2467
City
Sainte-Foy, Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Facility Name
Site Reference ID/Investigator# 66804
City
Scarborough
ZIP/Postal Code
M1B 4Y9
Country
Canada
Facility Name
Site Reference ID/Investigator# 563
City
St. John's
ZIP/Postal Code
A1B 3E1
Country
Canada
Facility Name
Site Reference ID/Investigator# 2466
City
Toronto
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Site Reference ID/Investigator# 567
City
Toronto
ZIP/Postal Code
M5L 3L9
Country
Canada
Facility Name
Site Reference ID/Investigator# 3442
City
Vancouver
ZIP/Postal Code
V5Z 1L7
Country
Canada
Facility Name
Site Reference ID/Investigator# 514
City
Winnipeg
ZIP/Postal Code
R3A 1M4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
26199453
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.
Results Reference
derived

Learn more about this trial

Long Term Open Label Continuation Study

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