Long Term Open Label Continuation Study

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00195650
• Date of registration: 13/09/2005
• Prospective Registration: No
• Primary sponsor: Abbott
• Public title: Long Term Open Label Continuation Study
• Scientific title: A Multi-Center Continuation Study of the Human Anti-TNF Antibody D2E7 Administered as a Subcutaneous Injection in Patients With Rheumatoid Arthritis
• Date of first enrolment: July 2000
• Target sample size: 846
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00195650
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Canada, United States

Contacts

• Name: Hartmut Kupper, MD
• Affiliation: Abbott

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Biological: Adalimumab

Primary Outcome(s)

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]

Number of Participants in Clinical Remission (Based on Modified Disease Activity Score) at Week 260 [Time Frame: Week 260]

Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 520 [Time Frame: Week 520]

Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 260 [Time Frame: Week 260]

Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 520 [Time Frame: Week 520]

Number of Participants in Clinical Remission (Based on Modified Disease Activity Score) at Week 520 [Time Frame: Week 520]

Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 260 [Time Frame: Week 260]

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]

Number of Participants Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 260 [Time Frame: Week 260]

Number of Participants Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 520 [Time Frame: Week 520]

Secondary Outcome(s)

Reported Adverse Events [Time Frame: Duration of study (up to 520 weeks [10 years])]

Secondary ID(s)

DE020

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 31/07/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00195650