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Long Term Open Label Continuation Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT00195650
First received: September 13, 2005
Last updated: August 24, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Biological: Adalimumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center Continuation Study of the Human Anti-TNF Antibody D2E7 Administered as a Subcutaneous Injection in Patients With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 520 [ Time Frame: Week 520 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 260 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 520 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 260 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 520 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 260 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 520 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 260 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline of prior Phase 1, 2, or 3 adalimumab study and Week 520 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline of prior Phase 1, 2, or 3 adalimumab study and Week 260 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Duration of study (up to 520 weeks [10 years]) ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 846
Study Start Date: July 2000
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adalimumab
Open-label adalimumab 40 mg
Biological: Adalimumab
Subcutaneous injection of 40 mg adalimumab every other week (eow) or monthly for up to 520 weeks (10 years)
Other Name: Humira, ABT-D2E7

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00195650

  Show 92 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Study Director: Hartmut Kupper, MD Abbott
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT00195650     History of Changes
Other Study ID Numbers: DE020
Study First Received: September 13, 2005
Results First Received: May 4, 2012
Last Updated: August 24, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Abbott:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014