N/A
Completed N=1,613
A Study to Investigate the Use of Golimumab (Simponi®) in Participants With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis (P06554)
Arthritis, Rheumatoid · Arthritis, Psoriatic · Spondylitis, Ankylosing
Source: ClinicalTrials.gov NCT01313858 ↗
Enrolled (actual)
1,613
Serious AEs
12.7%
Results posted
Nov 2016
Primary outcomePrimary: Clinical Global Impression (CGI) Disease Status — 5.7; 5.5; 5.7; 3.4 Units on a scale
Summary
This is a study to assess the use of golimumab (Simponi®) in participants with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. The study objective is to evaluate the clinical safety of golimumab (Simponi®) under real-life, clinical practice conditions as assessed by the incidence and type of (serious) adverse events and changes in clinical status of participants as assessed by clinical parameters.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Global Impression (CGI) Disease Status |
5.7; 5.5; 5.7; 3.4; 3.2; 2.9 | — |
| PRIMARY Change From Baseline in FFbH (Funktionsfragebogen Hannover) Questionnaire Score |
5.29; 5.82; 8.66; 5.71; 6.31; 10.01 | 0.0007 sig |
| PRIMARY Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score |
2.85; 4.39; 5.21; 3.71; 4.40; 5.71 | 0.0003 sig |
| PRIMARY Change From Baseline in EuroQol- 5 Dimension 3 Level Version (EQ-5D-3L) Questionnaire Score |
-0.69; -1.07; -1.18; -0.97; -1.35; -1.24 | <0.0001 sig |
| PRIMARY Number of Participants Who Experienced at Least One Adverse Event |
320; 309; 281 | — |
| PRIMARY Number of Participants Who Experienced at Least One Serious Adverse Event |
75; 70; 59 | — |
Eligibility Criteria
Inclusion Criteria
- Has rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis and treatment with Simponi® by autoinjector device is to be initiated for the first time
Exclusion Criteria
- No specific exclusion criteria
Data sourced from ClinicalTrials.gov (NCT01313858). 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.