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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT01369745
Date of registration: 07/06/2011
Prospective Registration: Yes
Primary sponsor: Zalicus
Public title: A Phase II Trial Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis Synergy
Scientific 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
Date of first enrolment: June 2011
Target sample size: 294
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01369745
Study type:  Interventional
Study design:   
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Margaret Lee, PhD
Address: 
Telephone:
Email:
Affiliation:  Zalicus, Inc.
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: dipyridamole
Drug: Prednisolone
Drug: Prednisone
Drug: Z102
Other: placebo
Primary Outcome(s)
Change From Baseline in DAS28-CRP at 12 Weeks [Time Frame: baseline to week 12]
Secondary Outcome(s)
Change From Baseline in DAS28-CRP Individual Components at 12 Weeks [Time Frame: Baseline to week 12]
Multidimensional Assessment of Fatigue (MAF) at Week 12 [Time Frame: week 12]
Percentage of Subjects Achieving ACR20, ACR50 and ACR70 at 12 Weeks [Time Frame: Week 12]
Time to Failure (Days) [Time Frame: Baseline to 12 weeks]
Secondary ID(s)
Z102-008
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 30/04/2014
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01369745
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