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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 February 2015
Main ID:  NCT01612377
Date of registration: 22/02/2012
Prospective Registration: Yes
Primary sponsor: Zalicus
Public title: Long Term Safety Trial of z102 and Prednisone in Patients With Moderate to Severe Rheumatoid Arthritis
Scientific title: A Phase II, Double-blind, Controlled, Multi-center, Randomized, Long Term Safety Trial of z102 and Prednisone (5 mg or 7.5 mg) in Patients With Moderate to Severe Rheumatoid Arthritis
Date of first enrolment: March 2012
Target sample size: 18
Recruitment status: Terminated
URL:  http://clinicaltrials.gov/show/NCT01612377
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
Serbia
Contacts
Name:     Gene Wright, PHARM.D, PH.D
Address: 
Telephone:
Email:
Affiliation:  Zalicus, Inc
Key inclusion & exclusion criteria

Inclusion Criteria:

- Have completed all 12 weeks of Protocol Z102-008 or discontinued after participating
in at least 6 weeks of the randomized withdrawal portion of Z102-008 for acceptable
reasons

- Have met all inclusion/exclusion criteria for enrollment into Protocol Z102-008

- Have been on DMARD therapy for at least 90 days and have been on a stable DMARD dose
without dosage adjustment or modification for 6 weeks prior to enrollment into
Protocol Z102-008, and be able to maintain the same dose of conventional DMARD
therapy during Protocol Z102-009 participation

Exclusion Criteria:

- Did not complete 6 weeks of the double-blind section of Protocol Z102-008, or was
discontinued from Protocol Z102-008 for reasons of an AE, protocol violation, or
non-compliance

- Active cardiovascular disease, unless well controlled by appropriate treatment, for a
minimum of 3 months prior to screening for enrollment into Protocol Z102-008

- Currently taking aspirin for reasons other than for cardiovascular prophylaxis or
their total daily dose is greater than 325 mg

- Taking oral steroids at a daily prednisone dose, or the equivalent, of >10 mg/day
within the past 2 weeks

- Intraarticular, intramuscular, or intravenous glucocorticoids must not have been
given at least 6 weeks prior to entering study Protocol Z102-008 or Protocol
Z102-009, at any time during the study, or be anticipated to be given at any time
during the study

- The need to continue the use of one or multiple NSAIDs at the same time, or use
acetaminophen on a chronic basis

- All opiate use is prohibited.

- Use of any other medications or herbs or non-pharmacological treatments (e.g.,
acupuncture) used for the treatment of pain is prohibited

- Has, or has had, any active severe infections or recent invasive surgical procedures
within 30 days of Protocol Z102-008 or Protocol Z102-009 initiation

- HIV, hepatitis B, or hepatitis C infection

- Has undergone administration of any investigational drug within 30 days of study

- All biologic agents are excluded for 90 days prior to Screening and during the
conduct of Protocol Z102-008, and Protocol Z102-009

- Has undergone administration of rituximab or any B-cell depleting investigational
drugs within 6 months of Protocol Z102-008 Screening or Protocol Z102-009 initiation,
or at any time during participation in study Protocol Z102-008

- Has a history of hypersensitivity reaction to glucocorticoids and/or dipyridamole

- Known or suspected history of alcohol or drug abuse within 2 years prior to Screening
for Protocol Z102-008

- Has any other medical condition which may interfere with the conduct of this study in
the opinion of the investigator



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Prednisolone-Dipyridamole
Drug: prednisone
Primary Outcome(s)
Difference in incidence rates of adverse events between treament groups [Time Frame: 12 months]
Secondary Outcome(s)
Joint imaging [Time Frame: 12 months]
Secondary ID(s)
Z102-009
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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