N/A
Completed N=462
Physical Activity in Patients With Rheumatoid Arthritis Treated With Adalimumab in Routine Clinical Practice
Source: ClinicalTrials.gov NCT01756235 ↗Enrolled (actual)
462
Serious AEs
7.0%
Results posted
Mar 2017
Primary outcomePrimary: Mean Change From Baseline in Total Physical Activity Short Questionnaire to Assess Health-enhancing Physical Activity (SQUASH) Score — 870.0 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Total Physical Activity Short Questionnaire to Assess Health-enhancing Physical Activity (SQUASH) Score |
870.0 | — |
| SECONDARY Mean Change From Baseline in Total Physical Activity SQUASH Score |
454.9; 648.2; 611.3 | — |
| SECONDARY Mean Change From Baseline in SQUASH-A Scores |
-91.6; -41.7; 3.5; 10.4; -35.7 | — |
| SECONDARY Mean Change From Baseline in SQUASH-B Scores |
399.5; 497.9; 358.9; 831.3; 578.0 | — |
| SECONDARY Mean Change From Baseline in SQUASH-C Scores |
81.4; 154.6; 98.5; 315.4; 196.9 | — |
| SECONDARY Mean Change From Baseline in SQUASH-D Scores |
47.3; 27.2; 170.2; 136.2; 96.4 | — |
| SECONDARY Mean Change From Baseline in Disease Activity Index - 28 Joints (DAS28) Score |
-2.4; -2.8; -3.0; -3.3; -2.9 | — |
| SECONDARY Percentage of Participants in Clinical Disease Remission (DAS28<2.6) |
0.7; 21.3; 30.3; 32.3; 37.4; 31.1 | — |
| SECONDARY Percentage of Participants With Low Disease Activity State (LDAS, DAS28<3.2) |
1.3; 35.4; 46.4; 54.4; 66.2; 56.0 | — |
| SECONDARY Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants in Remission or LDAS |
473.3; -57.5; 438.3; 87.0; -11.3; 979.8 | — |
| SECONDARY 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 |
434.5; -134.8; 352.9; 75.1; 120.7; 203.6 | — |
| SECONDARY Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score |
-0.5; -0.7; -0.8; -0.9; -0.7 | — |
| SECONDARY Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and DAS28 Scores |
-0.19; -0.21; -0.06; -0.07; -0.10; -0.17 | — |
| SECONDARY Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and HAQ-DI Scores |
-0.30; -0.22; -0.16; -0.11; -0.21; -0.19 | — |
| SECONDARY Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Age Categories |
1066.2; 113.1; -27.5; -66.7; 770.8; -167.8 | — |
| SECONDARY Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Gender |
1500.1; 724.9; -133.9; -13.7; 948.3; 493.0 | — |
| SECONDARY Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Education |
831.7; 911.8; -45.2; -25.5; 520.5; 640.4 | — |
| SECONDARY Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Occupation |
1235.3; 518.4; 62.2; -131.3; 614.5; 544.1 | — |
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
Data sourced from ClinicalTrials.gov (NCT01756235). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.