Clinical trial NCT01756235: Physical Activity in Patients With Rheumatoid Arthritis Treated With Adalimumab in Routine Clinical Practice
Official title: Physical ACtivity in patiEnts With Rheumatoid Arthritis Treated With Adalimumab in Routine Clinical Practice (PACE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Post-marketing observational study (PMOS) Protocol
Rheumatoid Arthritis
Physical Activity
Adalimumab
Humira®
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2012-12-25
Enrollment: 462
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population consisted of participants with rheumatoid arthritis (RA) who were treated with adalimumab as per locally approved label and prescription guidelines. The decision to be treated with adalimumab had to be independent from study inclusion.

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Mean Change From Baseline in Total Physical Activity Short Questionnaire to Assess Health-enhancing Physical Activity (SQUASH) Score
timeFrame: Month 0 (baseline) and Month 12 (Last Observation Carried Forward (LOCF))
Secondary outcomes:
measure: Mean Change From Baseline in Total Physical Activity SQUASH Score
timeFrame: Month 3, Month 6 and Month 9
measure: Mean Change From Baseline in SQUASH-A Scores
timeFrame: Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF
measure: Mean Change From Baseline in SQUASH-B Scores
timeFrame: Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF
measure: Mean Change From Baseline in SQUASH-C Scores
timeFrame: Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF
measure: Mean Change From Baseline in SQUASH-D Scores
timeFrame: Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF
measure: Mean Change From Baseline in Disease Activity Index - 28 Joints (DAS28) Score
timeFrame: Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF
measure: Percentage of Participants in Clinical Disease Remission (DAS28<2.6)
timeFrame: Month 0, Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF
measure: Percentage of Participants With Low Disease Activity State (LDAS, DAS28<3.2)
timeFrame: Month 0, Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF
measure: Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants in Remission or LDAS
timeFrame: Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF
measure: Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants Those Who Did Not Attain Remission or LDAS
timeFrame: Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF
measure: Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score
timeFrame: Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF
measure: Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and DAS28 Scores
timeFrame: Month 0 and Month 12 LOCF
measure: Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and HAQ-DI Scores
timeFrame: Month 0 and Month 12 LOCF
measure: Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Age Categories
timeFrame: Month 0 and Month 12 LOCF
measure: Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Gender
timeFrame: Month 0 and Month 12 LOCF
measure: Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Education
timeFrame: Month 0 and Month 12 LOCF
measure: Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Occupation
timeFrame: Month 0 and Month 12 LOCF
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Elena Smirnova, MD
role: STUDY_DIRECTOR
References: