N/A
Completed N=1,117
Observation of Treatment With Certolizumab Pegol in Daily Practice
Source: ClinicalTrials.gov NCT01069419 ↗Enrolled (actual)
1,117
Serious AEs
19.1%
Results posted
Sep 2015
Primary outcomePrimary: Clinical Remission at Visit 9 (Around Week 104) Measured by Achieving a Disease Activity Score 28 (DAS28) of < 2.6 — 14.1 percentage of participants
Summary
This is an observational, non-interventional, non-comparative, post-authorization safety study to evaluate efficacy and long-term safety of Cimzia in adult patients with RA in need of treatment with a biological product.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Remission at Visit 9 (Around Week 104) Measured by Achieving a Disease Activity Score 28 (DAS28) of < 2.6 |
14.1 | — |
| SECONDARY Change From Baseline to Visit 9 (Around Week 104) in Patients's Arthritis Pain as Measured by Patient's Assessment of Arthritis Pain (PAAP) Visual Analog Scale (VAS) |
-16.43 | — |
| SECONDARY Change From Baseline to Visit 9 (Around Week 104) in Patient's Physical Function as Measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) |
-0.26 | — |
| SECONDARY Change From Baseline to Visit 9 (Around Week 104) in Disease Activity Measured by Clinical Disease Activity Index (CDAI) |
-14.57 | — |
Eligibility Criteria
Inclusion Criteria
- Patients eligible for treatment with Cimzia as defined in EU approved SmPC
Exclusion Criteria
- Patient previously treated with Cimzia. Patient with known hypersensitivity to any component of Cimzia
Data sourced from ClinicalTrials.gov (NCT01069419). 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.