N/A
Completed N=1,061
An Observational Study of Infliximab Injection in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Participants
Spondylitis, Ankylosing · Arthritis, Rheumatoid · Psoriasis · Arthritis, Psoriatic
Source: ClinicalTrials.gov NCT00760669 ↗
Enrolled (actual)
1,061
Serious AEs
1.1%
Results posted
Aug 2013
Primary outcomePrimary: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 30 — 7.52; -5.23 Millimeter
Summary
The purpose of this observational study is to evaluate the safety and effectiveness of infliximab injection under actual conditions of use in participants, and to learn more about its adverse events.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 30 |
7.52; -5.23 | — |
| PRIMARY Change From Baseline in Erythrocytic Sedimentation Rate (ESR) at Week 30 |
60.75; -21.80 | — |
| PRIMARY Change From Baseline in C-Reactive Protein (CRP) at Week 30 |
7.94; -4.81 | — |
| PRIMARY Change From Baseline in Number of Swollen Joints at Week 30 |
9.75; -5.46 | — |
| PRIMARY Change From Baseline in Number of Tender Joints at Week 30 |
13.31; -7.35 | — |
| PRIMARY Change From Baseline in Participants With Psoriasis Area and Severity Index (PASI) at Week 30 |
— | — |
| PRIMARY Overall Efficacy Assessment |
948; 59; 24 | — |
| PRIMARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
106; 12 | — |
| PRIMARY Number of Participants With Unexpected Adverse Events |
28 | — |
| PRIMARY Number of Participants With Adverse Drug Reactions |
59 | — |
| PRIMARY Number of Participants With Adverse Events (AEs) Caused by Drug Misuse, Abuse and Drug Interaction |
48 | — |
Eligibility Criteria
Inclusion Criteria
- Participants with ankylosing spondylitis who did not show adequate response to general treatments and with increased serological indices related to severe axial symptoms and inflammation
- Participants with rheumatoid arthritis who show insufficient response to disease modifying antirheumatic drug (DMARD) including methotrexate
- Participants with serious, active and progressive disease not previously treated with methotrexate or other DMARD
- Participant with moderate to serious plaque psoriasis who are unresponsive, contra indicant or intolerable to the systemic therapy including cyclosporine, methotrexate or Psoralen Ultra-Violet A (PUVA)
- Participant with active, progressive, psoriatic arthritis who have shown insufficient response to DMARD treatment
Exclusion Criteria
None
Data sourced from ClinicalTrials.gov (NCT00760669). 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.