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

Information source: Zalicus
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Prednisolone (Drug); dipyridamole (Drug); Prednisone (Drug); Z102 (Drug); placebo (Other)

Phase: Phase 2

Status: Completed

Sponsored by: Zalicus

Official(s) and/or principal investigator(s):
Margaret Lee, PhD, Study Director, Affiliation: Zalicus, Inc.

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.

Clinical Details

Official title: A Phase II, Double-Blind, Placebo-Controlled, Multi-Center, Randomized Withdrawal Design Trial Using Adaptive Randomization Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change From Baseline in DAS28-CRP at 12 Weeks

Secondary outcome:

Change From Baseline in DAS28-CRP Individual Components at 12 Weeks

Percentage of Subjects Achieving ACR20, ACR50 and ACR70 at 12 Weeks

Multidimensional Assessment of Fatigue (MAF) at Week 12

Time to Failure (Days)

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Zalicus Investigational Site, Toledo, Ohio 43606, United States
Additional Information

Starting date: June 2011
Last updated: April 29, 2014

Page last updated: August 23, 2015

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