Phase 2
N=59
A Study Comparing CRx-102 Plus Disease-modifying Anti-rheumatic Drug (DMARD) Therapy to Placebo Plus DMARD Therapy in RA
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT00747214 ↗Enrolled (actual)
59
Serious AEs
1.7%
Results posted
May 2014
Primary outcome: Primary: Change in CRP From Baseline to Day 42 — -16.12; 9.60 percentage change from baseline
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CRx-102 (Drug); Placebo (Drug); DMARD Therapy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zalicus
- Primary completion
- Sep 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in CRP From Baseline to Day 42 |
-16.12; 9.60 | — |
| SECONDARY Improvement of ACR 20 Scores at End of Study (Day 42/Visit 5) |
63; 30 | — |
| SECONDARY Change in DAS28 Score From Baseline to Day 42 |
-1.521; -0.697 | — |
| SECONDARY Change in Fatigue (MAF Scale) Score From Baseline to Day 42 |
-7.840; -2.965 | — |
Summary
This study was a Multicenter, Randomized, Blinded Study Comparing the Effect of CRx-102 Plus DMARD Therapy to that of Placebo Plus DMARD Therapy on Serum C Reactive Protein (CRP) and Cytokines in Subjects with Rheumatoid Arthritis. This Phase II, 6-week blinded study was planned for 60 subjects with moderate to severe rheumatoid arthritis (RA).
Eligibility Criteria
Inclusion Criteria
- Was 18 years of age of older
- Had moderate to severe RA
- Had at least 3 swollen joints (maximum 28) and 3 tender joints (maximum 28)
- Had a Baseline CRP level of at least 2.2 mg/L and a DAS28 score >4.5
- Had been on DMARD therapy for at least 3 months and have been on a stable dose of DMARD therapy for at least 28 days prior to enrollment
- Had a negative pregnancy test (females)
- Was not taking glucocorticoids at screening
Exclusion Criteria
- Female subject is pregnant or lactating or of child bearing potential not using acceptable methods of birth control (barriers or abstinence). Female subjects using hormonal birth control are not to be enrolled.
- Subject is currently taking any steroids (glucocorticoids). All glucocorticoids must be discontinued for at least one month prior to entering study. Intraarticular, intramuscular, or intravenous glucocorticoids must not have been given at least 6 weeks prior to entering the study.
- Subject is currently taking more than 81 mg of aspirin daily.
- Subject is currently taking a statin, unless she/he has been on a stable dose of the same statin for at least 3 months prior to entering into the trial.
- Subject has any active infections or recent surgical procedures within 30 days of study initiation.
- Subject has uncontrolled diabetes mellitus as defined by a HbA1C value ≥ 7.0%.
- Subject knowingly has HIV or Hepatitis.
- Subject has undergone administration of any investigational drug within 30 days of study initiation.
- Subject has a history of hypersensitivity to steroids and/or dipyridamole.
- Subject has limited mental capacity or language skills such that simple instructions cannot be followed or information regarding adverse events cannot be provided.
Data sourced from ClinicalTrials.gov (NCT00747214). 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.