A Phase II Trial Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis (Synergy)

Zalicus

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Prednisone; Drug: Z102; Drug: dipyridamole; Other: placebo; Drug: Prednisolone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01369745

Z102-008

Details and patient eligibility

About

Thus study will test an experimental drug called Z-102 (combination of prednisolone and dipyridamole) to treat patients with moderate to severe rheumatoid arthritis.

Full description

The primary objective of the study was to demonstrate the efficacy of Z102 (2.7 mg prednisolone/360 mg dipyridamole) versus placebo on the Disease Activity Score 28 using C reactive protein (DAS28-CRP) in subjects with rheumatoid arthritis at the study endpoint of 12 weeks

Enrollment: 294 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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294 participants in 5 patient groups, including a placebo group

Prednisolone

Active Comparator group

Description:

Prednisolone 2.7 mg daily for 12 weeks

Treatment:

Drug: Prednisolone

dipyridamole

Active Comparator group

Description:

Dipyridamole 360 mg daily for 12 weeks

Treatment:

Drug: dipyridamole

prednisone

Active Comparator group

Description:

Prednisone 5 mg daily for 12 weeks

Treatment:

Drug: Prednisone

Z102 (2.7/360)

Experimental group

Description:

Prednisolone 2.7 mg plus dipyridamole 360 mg daily for 12 weeks

Treatment:

Drug: Z102

placebo

Placebo Comparator group

Description:

Placebo daily for 12 weeks

Treatment:

Other: placebo