Phase 4
Completed N=37
Can TNF-Alpha Incomplete Secondary Responders Attain a Safe and Efficacious Response Switching to Cimzia
Source: ClinicalTrials.gov NCT01147341 ↗Enrolled (actual)
37
Serious AEs
2.3%
Results posted
Mar 2014
Primary outcomePrimary: Proportion of Subjects Achieving a Clinical Disease Activity Index (CDAI) Decrease of Greater Than or Equal to 10 Points in the Cimzia Treatment Group Compared to the Placebo Group at Week 12 — 22; 2 participants
Summary
Purpose of the study is to determine if Cimzia is safe and effective in subjects who have received previous treatment with a TNF-alpha inhibitor other than Cimzia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects Achieving a Clinical Disease Activity Index (CDAI) Decrease of Greater Than or Equal to 10 Points in the Cimzia Treatment Group Compared to the Placebo Group at Week 12 |
22; 2 | — |
| PRIMARY Proportion of Subjects Achieving an American College of Rheumatology 20% (ACR20) Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group |
12; 5 | — |
| SECONDARY Proportion of Subjects Achieving an American College of Rheumatology 50% (ACR50) Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group at Week 12 |
5; 0 | — |
| SECONDARY Proportion of Subjects Achieving an American College of Rheuamtology Low Disease Activity Score and/or Remission Score in the Cimzia Group Compared to the Placebo Group as Calculated by DAS28 (CRP) |
7; 3 | — |
| SECONDARY Proportion of Subjects Achieving a EULAR Good or Moderate Response Criteria in the Cimzia Treatment Group Compared to the Placebo Group |
17; 6 | — |
| SECONDARY Proportion of Subjects Achieving a CDAI Score Decrease Greater Than or Equal to 13.9 Points in the CimZia Treatment Group Compared to the Placebo Group at Week 12 |
17; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Have a diagnosis of RA at least 6 months
- Have received treatment with a TNF-alpha inhibitor
- Be receiving Methotrexate (with folic acid)at a dose of at least 10mg/week or another non-biologic DMARD if Methotrexate intolerant *Have at least 6 tender joint and 6 swollen joints*
- Have an CRP greater than or equal to ULN
- Availability of a chest x-ray that shows no evidence of active TB or infection
Exclusion Criteria
- Prior exposure to Cimzia
- Prior treatment with B-cell depleting therapy
- No significant response to previous TNF inhibitor
- Congestive heart failure
- Clinically abnormal laboratory tests
- History of cancer
- Active TB
Data sourced from ClinicalTrials.gov (NCT01147341). 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.