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

Zalicus

Status and phase

Terminated

Phase 2

Conditions

Rheumatoid Arthritis

Treatments

Drug: Prednisone

Drug: prednisone

Drug: Prednisolone-Dipyridamole

Study type

Interventional

Funder types

Industry

Identifiers

NCT01612377

Z102-009

Details and patient eligibility

About

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.

Full 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

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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