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

NCT01612377 | Terminated Phase 2

• 1 other identifier: Z102-009
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

Moderate to Severe

Outcome Measures

Primary Outcomes (1)

• Difference in incidence rates of adverse events between treament groups

  12 months

Secondary Outcomes (1)

• Joint imaging

  12 months

Study Arms (3)

prednisolone-dipyridamole

EXPERIMENTAL

Drug: Prednisolone-Dipyridamole

prednisone 5mg

ACTIVE COMPARATOR

Drug: Prednisone

prednisone 7.5mg

ACTIVE COMPARATOR

Drug: prednisone

Interventions

Prednisolone-Dipyridamole DRUG

Oral, QD

Also known as: Z102

prednisolone-dipyridamole

prednisone DRUG

Oral QD Prednisone 5mg

prednisone 5mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zalicus: lead

Study Sites (1)

Nemanja Damjanov

Belgrade, 11000, Serbia

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

dipyridamole, prednisolone drug combination; Prednisone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Gene Wright, PHARM.D, PH.D

  Zalicus, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2012
• First Posted: June 5, 2012
• Study Start: March 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 11, 2012

Record last verified: 2012-09

Locations

SE (1)