drugset / Trial / NCT01255761
A Comparison of Two Assessment Tools in Predicting Treatment Success of Cimzia in Rheumatoid Arthritis Subjects
RandomizedParallel-groupDouble-blindTreatment
Summary
Phase 4 study to evaluate a routine patient completed assessment (RAPID3) compared to a physician completed assessment (CDAI) to predict treatment success with subjects with moderate to severe rheumatoid arthritis
Timeline
- Start
- 2010-11
- Primary completion
- 2012-10
- Completion
- 2012-12
Outcome
Mixed primary results
registry Difference in proportion -0.119 (95% CI -0.184 to -0.053) NCT01255761 ↗
registry Difference in proportion -0.013 (95% CI -0.093 to 0.066) NCT01255761 ↗
paper Although these outcome measures were not statistically comparable, the positive predictive value for low disease activity at week 52 was similar. PMID 26316013 ↗
Publications
- Results Curtis JR, Herrem C, Ndlovu 'N, O'Brien C, Yazici Y. A somatization comorbidity phenotype impacts response to therapy in rheumatoid arthritis: post-hoc results from the certolizumab pegol phase 4 PREDICT trial. Arthritis Res Ther. 2017 Sep 29;19(1):215. doi: 10.1186/s13075-017-1412-z.
- Curtis JR, Churchill M, Kivitz A, Samad A, Gauer L, Gervitz L, Koetse W, Melin J, Yazici Y. A Randomized Trial Comparing Disease Activity Measures for the Assessment and Prediction of Response in Rheumatoid Arthritis Patients Initiating Certolizumab Pegol. Arthritis Rheumatol. 2015 Dec;67(12):3104-12. doi: 10.1002/art.39322.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Certolizumab Pegol | Protein / enzyme biologic | 200 mg | Subcutaneous |