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

September 10, 2012 updated by: Zalicus

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

This study will compare an experimental drug called Z102 (combination of prednisolone and dipyridamole, against prednisone 5mg and prednisone 7.5mg in patients with moderate to severe Rheumatoid Arthritis for a period of 52 weeks.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a long-term Phase II safety study of approximately 52 weeks in duration. Eligible patients will have completed at least 6 weeks of Protocol Z102-008 and will have met all inclusion and exclusion criteria for this study.

All patients will be up-titrated on Z102 over 3 weeks or will receive prednisone 5.0 mg or 7.5 mg:

Primary objectives:

  • Adverse events (AEs)
  • Vital signs
  • Clinical laboratory and clinical chemistry evaluations

Secondary objectives:

  • Joint imaging and bone density
  • DAS28-CRP and individual components
  • Patient Global Assessment of Disease Activity
  • American College of Rheumatology criteria (ACR 20, ACR 50, ACR 70)
  • Multidimensional Assessment of Fatigue (MAF)
  • Time to failure

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Serbia
      • Belgrade, Serbia, 11000
        • Nemanja Damjanov

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: prednisolone-dipyridamole
Drug: Prednisolone-Dipyridamole
Oral, QD
Other Names:
  • Z102
Active Comparator: prednisone 5mg
Drug: Prednisone
Oral QD Prednisone 5mg
Active Comparator: prednisone 7.5mg
Drug: prednisone
Oral, QD prednisone 7.5mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in incidence rates of adverse events between treament groups
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Joint imaging
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zalicus

Investigators

  • Study Director: Gene Wright, PHARM.D, PH.D, Zalicus, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

July 1, 2013

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

February 22, 2012

First Submitted That Met QC Criteria

June 1, 2012

First Posted (Estimate)

June 5, 2012

Study Record Updates

Last Update Posted (Estimate)

September 11, 2012

Last Update Submitted That Met QC Criteria

September 10, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Z102-009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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