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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01612377

Enrollment

Registered

2012-06-05

Start date

2012-03-31

Completion date

2013-09-30

Last updated

2012-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Moderate to Severe

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

Interventions

DRUGPrednisolone-Dipyridamole

Oral, QD

DRUGPrednisone

Oral QD Prednisone 5mg

DRUGprednisone

Oral, QD prednisone 7.5mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Difference in incidence rates of adverse events between treament groups	12 months

Secondary

Measure	Time frame
Joint imaging	12 months

Countries

Serbia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026