Phase 2
N=258
A Phase II Trial Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01369745 ↗Enrolled (actual)
258
Serious AEs
4.7%
Results posted
Apr 2014
Primary outcome: Primary: Change From Baseline in DAS28-CRP at 12 Weeks — -1.147; -0.813; -1.237; -0.907 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Prednisolone (Drug); dipyridamole (Drug); Prednisone (Drug); Z102 (Drug); placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zalicus
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in DAS28-CRP at 12 Weeks |
-1.147; -0.813; -1.237; -0.907; -0.538 | — |
| SECONDARY Change From Baseline in DAS28-CRP Individual Components at 12 Weeks |
— | — |
| SECONDARY Percentage of Subjects Achieving ACR20, ACR50 and ACR70 at 12 Weeks |
— | — |
| SECONDARY Multidimensional Assessment of Fatigue (MAF) at Week 12 |
— | — |
| SECONDARY Time to Failure (Days) |
— | — |
Summary
Thus study will test an experimental drug called Z-102 (combination of prednisolone and dipyridamole) to treat patients with moderate to severe rheumatoid arthritis.
Eligibility Criteria
Inclusion Criteria
- Meet the ACR / EULAR criteria for classification of RA
- Have moderate to severe RA, defined as involving a minimum (≥6 total swollen and ≥6 total tender) of the 28 joints assessed
- Have screening CRP levels of at least 0.6 mg/dl and a DAS28-CRP score ≥4.5
- Have been on a stable dose of conventional DMARD therapy for at least 90 days without dosage adjustment or modification and should be able to maintain the same dose of conventional DMARD therapy during study participation (with or without glucocorticoid therapy
Exclusion Criteria
- Treatment-refractory patients are excluded
- Has active cardiovascular disease, unless well controlled by appropriate treatment for a minimum of 3 months prior to screening
- Is taking aspirin for reasons other than for cardiovascular prophylaxis or their total daily dose is greater than 325 mg
- Is currently taking steroids at a daily prednisone dose, or the equivalent, of >10 mg
- Intraarticular, intramuscular, or intravenous glucocorticoids must not have been given at least 6 weeks prior to entering the study
- The need to continue the use of one or multiple NSAID's at the same time, or the use of acetaminophen on a chronic basis
- All opiate use is prohibited
- Use of any other medications or herbs used for the treatment of pain is prohibited
- Patients with a history of or currently active tuberculosis as per specific country guidelines are excluded
- Has uncontrolled diabetes mellitus as defined by a serum glucose >126 mg/dl
- Knowingly has HIV infection or hepatitis
- Has undergone administration of any investigational drug within 30 days of study initiation
- All biologic agents are excluded for 90 days prior to Screening and throughout the study.
- Has undergone administration of rituximab or any B-cell depleting investigational drugs within 6 months of study initiation
- Has had a history of alcohol or drug abuse within the past 2 years
- Has a history of hypersensitivity to glucocorticoids and/or dipyridamole
Data sourced from ClinicalTrials.gov (NCT01369745). 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.