N/A
Completed N=149
Long Term Effects of an Early Response to Certolizumab Pegol (CZP, Cimzia®) in Rheumatoid Arthritis (RA) Patients
Arthritis,Rheumatoid
Source: ClinicalTrials.gov NCT01288287 ↗
Enrolled (actual)
149
Serious AEs
5.4%
Results posted
Jun 2016
Primary outcomePrimary: Percentage of Participants With a Disease Activity Score (DAS) Response at 78 Weeks Where DAS Response is Defined as a Reduction From Baseline in DAS 28-joint Count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] Score of Greater Than 1.2 Points — 79.5; 50.0 percentage of patients
Summary
To determine if early clinical response at 12 weeks to Certolizumab Pegol (CZP, Cimzia ®) therapy in adult Rheumatoid Arthritis (RA) patients is a predictor of better long term clinical response at 18 months compared with a lack of clinical response at 12 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Disease Activity Score (DAS) Response at 78 Weeks Where DAS Response is Defined as a Reduction From Baseline in DAS 28-joint Count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] Score of Greater Than 1.2 Points |
79.5; 50.0 | — |
| SECONDARY Change From Baseline in Disease Activity Score 28-joint Count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] Score at 78 Weeks |
-2.45; -1.63 | — |
| SECONDARY Percentage of Participants With a Disease Activity Score (DAS)-Based European League Against Rheumatoid Arthritis (EULAR) Response at 78 Weeks Compared to Baseline |
47.7; 35.7; 36.4; 50.0; 15.9; 14.3 | — |
| SECONDARY Change From Baseline in Rheumatoid Arthritis Disease Activity Index (RADAI) Scores at 78 Weeks |
-2.64; -1.78 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disease Index (HAQ-DI) Scores at 78 Weeks |
-0.43; -0.34 | — |
Eligibility Criteria
Inclusion Criteria
- Informed consent is signed and dated
- The patient is considered capable of and prepared to adhere to the study protocol procedures
- The patient is prescribed CZP according to the Summary of Product Characteristics (SmPC) (UK and Eire) and National Institute of Clinical Excellence (NICE) (UK only) guidelines for anti tumor necrosis factor (TNF) α therapy for Rheumatoid Arthritis (RA).
- The patient is screen-negative for tuberculosis
- The patient is 18 years of age or above
Exclusion Criteria
- The patient has been exposed previously to biological disease modifying anti rheumatic drugs (DMARD) agents.
- Patient has previously participated in this study or the patient has previously been assigned to treatment in a study of CZP or another biological agent used to treat RA.
- Patient has participated in another study within the last 30 days
- Patient has any medical or psychiatric condition that, in the opinion of the physician, can jeopardize or would compromise the patient's ability to adequately participate in the study
- Patient has inadequate literacy to understand and complete the questionnaires.
- Contraindications stated in the SmPC
- Patient is pregnant or breast feeding
Data sourced from ClinicalTrials.gov (NCT01288287). 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.