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

This study has been terminated.
(missed endpoint of meaningful clinical benefit, compared to prednisolone 2.7mg)
Sponsor:
Information provided by (Responsible Party):
Zalicus
ClinicalTrials.gov Identifier:
NCT01612377
First received: February 22, 2012
Last updated: September 10, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: Prednisolone-Dipyridamole
Drug: Prednisone
Drug: prednisone
Phase 2

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
Official 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

Resource links provided by NLM:


Further study details as provided by Zalicus:

Primary Outcome Measures:
  • Difference in incidence rates of adverse events between treament groups [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Joint imaging [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: March 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: prednisolone-dipyridamole Drug: Prednisolone-Dipyridamole
Oral, QD
Other Name: Z102
Active Comparator: prednisone 5mg Drug: Prednisone
Oral QD Prednisone 5mg
Other Name: prednisone
Active Comparator: prednisone 7.5mg Drug: prednisone
Oral, QD prednisone 7.5mg
Other Name: prednisone

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01612377

Locations
Serbia
Nemanja Damjanov
Belgrade, Serbia, 11000
Sponsors and Collaborators
Zalicus
Investigators
Study Director: Gene Wright, PHARM.D, PH.D Zalicus, Inc
  More Information

No publications provided

Responsible Party: Zalicus
ClinicalTrials.gov Identifier: NCT01612377     History of Changes
Other Study ID Numbers: Z102-009
Study First Received: February 22, 2012
Last Updated: September 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Zalicus:
Moderate to Severe

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methylprednisolone acetate
Prednisolone acetate
Prednisone
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Dipyridamole
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014