Post-marketing Observational Study in Subjects With Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00234884
• Date of registration: 16/09/2005
• Prospective Registration: No
• Primary sponsor: Abbott
• Public title: Post-marketing Observational Study in Subjects With Rheumatoid Arthritis ReAlise
• Scientific title: A Five-year, Post-marketing Observational Study to Follow-up Patients With Rheumatoid Arthritis Formerly Treated in Study M02-497 (ReAct) and Subsequently Prescribed Humira
• Date of first enrolment: September 2003
• Target sample size: 3435
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00234884
• Study type: Observational

Countries of recruitment

Australia, Austria, Belgium, France, Germany, Greece, Italy, Netherlands, Portugal, Spain, United Kingdom

Contacts

• Name: Laura Redden, MD, PhD
• Affiliation: Abbott

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participants with ongoing adalimumab treatment who completed at least Month 3 (Visit
5) of NCT00448383 (Study M02-497) and who had subsequently been prescribed adalimumab
according to the Summary of Product Characteristics (SmPC).

- Participants must have been willing to consent to data being collected and provided to
Abbott.

Exclusion Criteria:

· Participants with contraindications according to the SmPC.



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)

American College of Rheumatology 20% (ACR20) Response Rate [Time Frame: Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value]

American College of Rheumatology 50% (ACR50) Response Rate [Time Frame: Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value]

American College of Rheumatology 70% (ACR70) Response Rate [Time Frame: Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value]

Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) [Time Frame: Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value]

Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR) [Time Frame: Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value]

Secondary ID(s)

M03-634

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 30/09/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00234884