Long Term Safety Trial of z102 and Prednisone in Patients With Moderate to Severe Rheumatoid Arthritis

• 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
• 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