Physical Activity in Patients With Rheumatoid Arthritis Treated With Adalimumab in Routine Clinical Practice (PACE)
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About
The purpose of this study was to evaluate physical activity and its changes in participants with rheumatoid arthritis (RA) who were treated with adalimumab therapy in clinical practice.
Full description
This post-marketing observational study was conducted in a multi-country, multi-center and single-arm format. Data were collected prospectively. Adult participants with diagnosis of RA who were assigned for treatment with adalimumab (Humira®) were eligible for participation. During this period four follow-up visits were planned for observation of the participant and documentation of data. Ideally, these visits should have been performed approximately 3 (V1), 6 (V2), 9 (V3) and 12 (V4) months after the baseline visit (V0).
Enrollment
Sex
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Volunteers
Inclusion criteria
- Had rheumatoid arthritis (RA) and is eligible to start and/or continue adalimumab therapy according to the local product label and prescription guidelines
- Had been started on adalimumab therapy no more than one (1) month prior to the study enrolment
- Had negative result of tuberculosis (TB) screening test or was receiving TB prophylaxis as per local guidelines
- Had provided written Authorization to the investigator to use and/or disclose personal and/or health data, or Informed Consent if requested by the Local Regulations
Exclusion criteria
- Was unable to walk either due to RA or a comorbid condition
- Was unable to perform basic self-care activities
- Had contraindications for treatment with adalimumab
Trial design
462 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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