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Multicenter Study to Evaluate CRx-102 vs. Each of Its Components to Treat Active Rheumatoid Arthritis

NCT00551707 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2014-04-29

Study results available
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Summary

CRx-102 is a synergistic combination drug candidate containing the cardiovascular drug dipyridamole and a very low dose of the glucocorticoid prednisolone. CRx-102 is believed to work through a novel mechanism of action in which dipyridamole selectively amplifies the anti-inflammatory and immunomodulatory activities of the glucocorticoid without replicating the dose-dependent adverse effects. CRx-102 has been associated with clinical benefit in proof of concept studies in subjects with hand Osteoarthritis (OA) and Rheumatoid Arthritis (RA).

In this trial, CRx-102 will be given to subjects with active RA as an add-on therapy to existing stable doses of Disease Modifying Anti-Rheumatic Drugs (DMARDs) including methotrexate (MTX), sulfasalazine, hydroxychloroquine, leflunomide or azathioprine. MTX in combination with other DMARDs (e.g., sulfasalazine or hydroxychloroquine) will be permitted to reflect the current standard of care practices within rheumatology.

Conditions

Interventions

DRUG

CRx-102 (2.7/180)

prednisolone 2.7 mg plus dipyridamole 180 mg

DRUG

prednisolone

prednisolone (2.7 mg)

DRUG

dipyridamole

dipyridamole 360 mg

DRUG

placebo

placebo

DRUG

CRx-102 (2.7/360)

Prednisolone 2.7 mg plus Dipyridamole 360 mg

Sponsors & Collaborators

  • Zalicus

    lead INDUSTRY

Principal Investigators

  • Margaret Lee, PhD · Zalicus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-11-30
Completion
2009-01-31

Countries

  • United States
  • Argentina
  • Canada
  • Estonia
  • Hungary
  • Lithuania
  • Mexico
  • Poland
  • Romania
  • Russia
  • Serbia
  • South Africa

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00551707 on ClinicalTrials.gov