Clinical trial NCT01369745: A Phase II Trial Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis
Official title: A Phase II, Double-Blind, Placebo-Controlled, Multi-Center, Randomized Withdrawal Design Trial Using Adaptive Randomization Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Moderate to severe
Lead sponsor: Zalicus
Sponsor class: INDUSTRY
First posted: 2011-06-09
Enrollment: 294
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Thus study will test an experimental drug called Z-102 (combination of prednisolone and dipyridamole) to treat patients with moderate to severe rheumatoid arthritis.

Detailed description: The primary objective of the study was to demonstrate the efficacy of Z102 (2.7 mg prednisolone/360 mg dipyridamole) versus placebo on the Disease Activity Score 28 using C reactive protein (DAS28-CRP) in subjects with rheumatoid arthritis at the study endpoint of 12 weeks

Eligibility criteria: Inclusion Criteria:

* Meet the ACR / EULAR criteria for classification of RA
* Have moderate to severe RA, defined as involving a minimum (≥6 total swollen and ≥6 total tender) of the 28 joints assessed
* Have screening CRP levels of at least 0.6 mg/dl and a DAS28-CRP score ≥4.5
* Have been on a stable dose of conventional DMARD therapy for at least 90 days without dosage adjustment or modification and should be able to maintain the same dose of conventional DMARD therapy during study participation (with or without glucocorticoid therapy

Exclusion Criteria:

* Treatment-refractory patients are excluded
* Has active cardiovascular disease, unless well controlled by appropriate treatment for a minimum of 3 months prior to screening
* Is taking aspirin for reasons other than for cardiovascular prophylaxis or their total daily dose is greater than 325 mg
* Is currently taking steroids at a daily prednisone dose, or the equivalent, of \>10 mg
* Intraarticular, intramuscular, or intravenous glucocorticoids must not have been given at least 6 weeks prior to entering the study
* The need to continue the use of one or multiple NSAID's at the same time, or the use of acetaminophen on a chronic basis
* All opiate use is prohibited
* Use of any other medications or herbs used for the treatment of pain is prohibited
* Patients with a history of or currently active tuberculosis as per specific country guidelines are excluded
* Has uncontrolled diabetes mellitus as defined by a serum glucose \>126 mg/dl
* Knowingly has HIV infection or hepatitis
* Has undergone administration of any investigational drug within 30 days of study initiation
* All biologic agents are excluded for 90 days prior to Screening and throughout the study.
* Has undergone administration of rituximab or any B-cell depleting investigational drugs within 6 months of study initiation
* Has had a history of alcohol or drug abuse within the past 2 years
* Has a history of hypersensitivity to glucocorticoids and/or dipyridamole

Primary outcomes:
measure: Change From Baseline in DAS28-CRP at 12 Weeks
timeFrame: baseline to week 12
Secondary outcomes:
measure: Change From Baseline in DAS28-CRP Individual Components at 12 Weeks
timeFrame: Baseline to week 12
measure: Percentage of Subjects Achieving ACR20, ACR50 and ACR70 at 12 Weeks
timeFrame: Week 12
measure: Multidimensional Assessment of Fatigue (MAF) at Week 12
timeFrame: week 12
measure: Time to Failure (Days)
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Toledo
country: United States
facility: Zalicus Investigational Site
state: Ohio
Study officials:
affiliation: Zalicus, Inc.
name: Margaret Lee, PhD
role: STUDY_DIRECTOR
References: