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

NCT ID: NCT01612377

Last Updated: 2012-09-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-09-30

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.

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

Conditions

Rheumatoid Arthritis

Keywords

Moderate to Severe

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

prednisolone-dipyridamole

Group Type: EXPERIMENTAL

Prednisolone-Dipyridamole

Intervention Type: DRUG

Oral, QD

prednisone 5mg

Group Type: ACTIVE_COMPARATOR

Prednisone

Intervention Type: DRUG

Oral QD Prednisone 5mg

prednisone 7.5mg

Group Type: ACTIVE_COMPARATOR

prednisone

Intervention Type: DRUG

Oral, QD prednisone 7.5mg

Interventions

Prednisolone-Dipyridamole

Oral, QD

Intervention Type: DRUG

Prednisone

Oral QD Prednisone 5mg

Intervention Type: DRUG

prednisone

Oral, QD prednisone 7.5mg

Intervention Type: DRUG

Other Intervention Names

Z102

Eligibility 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

Exclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zalicus

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gene Wright, PHARM.D, PH.D

Role: STUDY_DIRECTOR

Zalicus, Inc

Locations

Nemanja Damjanov

Belgrade, , Serbia

Countries

Serbia

Other Identifiers

Z102-009

Identifier Type: -

Identifier Source: org_study_id