N/A
Completed N=5,920
A Belgian Registry of HUMIRA® (Adalimumab) in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis ( ProAct )
Source: ClinicalTrials.gov NCT01078558 ↗Enrolled (actual)
5,920
Serious AEs
15.8%
Results posted
Jul 2019
Primary outcomePrimary: Change From Baseline in Physician's Assessment of Disease Activity Over Time — -34.4; -36.2; -40.2; -38.6 units on a scale
Summary
This is a five year, post-marketing observational study to follow-up patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis who are treated with HUMIRA (adalimumab).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Physician's Assessment of Disease Activity Over Time |
-34.4; -36.2; -40.2; -38.6; -40.2; -44.5 | — |
| PRIMARY Change From Baseline in Tender Joints Over Time |
-8.5; -6.8; -1.6; -9.4; -7.6; -1.9 | — |
| PRIMARY Change From Baseline in Swollen Joints Over Time |
-7.3; -5.6; -1.3; -8.2; -6.1; -1.4 | — |
| PRIMARY Inflammatory Parameter: Change From Baseline in CRP Over Time |
-2.1; -1.6; -2.8; -1.9; -1.8; -2.6 | — |
| PRIMARY Inflammatory Parameter: Change From Baseline in ESR Over Time |
-8.3; -7.0; -11.7; -8.1; -8.1; -10.5 | — |
| PRIMARY Physical Function: Change From Baseline in HAQ% Over Time |
-19.4; -19.1; -19.6; -22.9; -23.2; -25.8 | — |
| PRIMARY Change From Baseline in DAS28 Over Time: RA Participants |
-1.77; -2.01; -2.38; -2.29; -2.53 | — |
| PRIMARY DAS28 Category Over Time: RA Participants |
106; 50; 118; 135; 49; 97 | — |
| PRIMARY BSA With PsA Over Time: PsA Participants |
398; 97; 32; 11; 378; 59 | — |
| PRIMARY Change From Baseline in Patient's Numerical Rating Scale Over Time: Oligoarticular PsA Participants |
-3.4; -3.8; -2.8; -4.1; -5.3 | — |
| PRIMARY Change From Baseline in Physician's Numerical Rating Scale Over Time: Oligoarticular PsA Participants |
-3.8; -4.3; -3.3; -4.0; -5.2 | — |
| PRIMARY Change From Baseline in BASDAI Over Time: AS Participants |
-3.1; -3.2; -3.4; -3.1; -3.3 | — |
| PRIMARY Number of Participants With Adverse Events (AEs) Serious AEs (SAEs), and AEs Leading to Study Drug Discontinuation |
976; 323; 493; 560; 164; 210 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with ongoing HUMIRA (adalimumab) treatment who have been prescribed HUMIRA (adalimumab) within local reimbursement guidelines.
- Patients must be willing to consent to data being collected and provided to Abbott Laboratories.
Exclusion Criteria
- Contraindications according to the summary of product characteristics.
- Patients who are actually followed in the ReAlise registry (M03-634 NCT00234884).
Data sourced from ClinicalTrials.gov (NCT01078558). 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.