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A Phase II Trial Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis (Synergy)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zalicus
ClinicalTrials.gov Identifier:
NCT01369745
First received: June 7, 2011
Last updated: September 10, 2012
Last verified: June 2012
History of Changes
  Purpose

Thus study will test an experimental drug called Z-102 (combination of prednisolone and dipyridamole) to treat patients with moderate to severe rheumatoid arthritis.


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: Prednisolone
Drug: dipyridamole
Drug: Prednisone
Drug: prednisolone-dipyridamole
Other: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Zalicus:

Primary Outcome Measures:
  • Disease Activity Score 28 C-reactive protein [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • American College of Rheumatology 20, 50, 70 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Multidimensional assessment of fatigue [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 259
Study Start Date: June 2011
Study Completion Date: September 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prednisolone Drug: Prednisolone
qd
Active Comparator: dipyridamole Drug: dipyridamole
qd
Active Comparator: prednisone Drug: Prednisone
qd
Experimental: prednisolone-dipyridamole Drug: prednisolone-dipyridamole
qd
Placebo Comparator: placebo Other: placebo
qd

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01369745

Locations
United States, Ohio
Zalicus Investigational Site
Toledo, Ohio, United States, 43606
Sponsors and Collaborators
Zalicus
Investigators
Study Director: Gene Wright, PHARMD, PhD Zalicus, Inc.
  More Information

No publications provided

Responsible Party: Zalicus
ClinicalTrials.gov Identifier: NCT01369745     History of Changes
Other Study ID Numbers: Z102-008
Study First Received: June 7, 2011
Last Updated: September 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Zalicus:
Rheumatoid Arthritis
Moderate to severe

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Dipyridamole
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisone
 Prednisolone hemisuccinate
Prednisolone phosphate
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Vasodilator Agents
Cardiovascular Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 19, 2013