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Trial record 54 of 117 for:    "Connective Tissue Disease" | "Methylprednisolone"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01612377
Recruitment Status : Terminated (missed endpoint of meaningful clinical benefit, compared to prednisolone 2.7mg)
First Posted : June 5, 2012
Last Update Posted : September 11, 2012
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Prednisolone-Dipyridamole Drug: Prednisone Drug: prednisone Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2012
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Prednisone

Arm Intervention/treatment
Experimental: prednisolone-dipyridamole Drug: Prednisolone-Dipyridamole
Oral, QD
Other Name: Z102

Active Comparator: prednisone 5mg Drug: Prednisone
Oral QD Prednisone 5mg

Active Comparator: prednisone 7.5mg Drug: prednisone
Oral, QD prednisone 7.5mg

Primary Outcome Measures :
  1. Difference in incidence rates of adverse events between treament groups [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Joint imaging [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01612377

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

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Responsible Party: Zalicus Identifier: NCT01612377     History of Changes
Other Study ID Numbers: Z102-009
First Posted: June 5, 2012    Key Record Dates
Last Update Posted: September 11, 2012
Last Verified: September 2012

Keywords provided by Zalicus:
Moderate to Severe

Additional relevant MeSH terms:
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Connective Tissue Diseases
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents