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

NCT ID: NCT01369745

Last Updated: 2014-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 294 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-09-30

Brief 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.

Detailed 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

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Prednisolone

Prednisolone 2.7 mg daily for 12 weeks

Group Type: ACTIVE_COMPARATOR

Prednisolone

Intervention Type: DRUG

Prednisolone 2.7 mg daily

dipyridamole

Dipyridamole 360 mg daily for 12 weeks

Group Type: ACTIVE_COMPARATOR

dipyridamole

Intervention Type: DRUG

dipyridamole 360 mg daily

prednisone

Prednisone 5 mg daily for 12 weeks

Group Type: ACTIVE_COMPARATOR

Prednisone

Intervention Type: DRUG

Prednisone 5 mg daily

Z102 (2.7/360)

Prednisolone 2.7 mg plus dipyridamole 360 mg daily for 12 weeks

Group Type: EXPERIMENTAL

Z102

Intervention Type: DRUG

Prednisolone 2.7 mg plus dipyridamole 360 mg daily

placebo

Placebo daily for 12 weeks

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

Interventions

Prednisolone

Prednisolone 2.7 mg daily

Intervention Type: DRUG

dipyridamole

dipyridamole 360 mg daily

Intervention Type: DRUG

Prednisone

Prednisone 5 mg daily

Intervention Type: DRUG

Z102

Prednisolone 2.7 mg plus dipyridamole 360 mg daily

Intervention Type: DRUG

placebo

Intervention Type: OTHER

Other Intervention Names

prednisolone; dipyridamole

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zalicus

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Margaret Lee, PhD

Role: STUDY_DIRECTOR

Zalicus, Inc.

Locations

Zalicus Investigational Site

Toledo, Ohio, United States

Countries

United States

Other Identifiers

Z102-008

Identifier Type: -

Identifier Source: org_study_id