Phase 2
Completed N=106
A Study of a Novel Investigational Drug in Rheumatoid Arthritis Patients (MK-0873-012)(COMPLETED)
Source: ClinicalTrials.gov NCT00132769 ↗Enrolled (actual)
106
Serious AEs
2.8%
Results posted
Feb 2014
Primary outcomePrimary: Change From Baseline in Swollen Joint Count — -7.20; -8.68 score on a scale — p=0.278
Summary
This study will look at whether this new drug is effective in the treatment of rheumatoid arthritis, and at whether it is safe and well-tolerated by participants with the disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Swollen Joint Count |
-7.20; -8.68 | 0.278 |
| SECONDARY Percentage of Participants With American College of Rheumatology 20% Response [ACR20] |
39.62; 45.28 | 0.543 |
| SECONDARY Change From Baseline in Tender Joint Count |
— | — |
| SECONDARY Patient Global Assessment of Disease Activity |
— | — |
| SECONDARY Investigator Global Assessment of Disease Activity |
— | — |
| SECONDARY Patient Global Assessment of Response to Therapy |
— | — |
| SECONDARY Health Assessment Questionnaire Disability Index |
— | — |
| SECONDARY Patient's Assessment of Pain |
— | — |
| SECONDARY Ratio of On-treatment C-Reactive Protein to Baseline C-Reactive Protein |
0.90; 1.08 | 0.225 |
Eligibility Criteria
Inclusion Criteria
- Rheumatoid arthritis, according to the American College of Rheumatology criteria, with active disease despite current medications
- Other criteria also apply
Exclusion Criteria
- Other major illnesses
- Past history of certain other disorders
- Certain prohibited medications
Data sourced from ClinicalTrials.gov (NCT00132769). 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.