A Phase II Trial Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Prednisolone; dipyridamole; Prednisone; Z102; placebo
Intervention description: Prednisolone 2.7 mg daily; dipyridamole 360 mg daily; Prednisone 5 mg daily; Prednisolone 2.7 mg plus dipyridamole 360 mg daily
Intervention MeSH terms: Prednisone; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Dipyridamole; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 294.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; Moderate to severe

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