Physical Activity in Patients With Rheumatoid Arthritis Treated With Adalimumab in Routine Clinical Practice

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

462 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-10-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Rheumatoid Arthritis

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with Rheumatoid Arthritis

Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No