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NCT00551707 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Rheumatoid Arthritis, sponsored by Zalicus.

Completed
Registry status
Phase 2
Development phase
51
Enrollment target
20
Study locations

NCT00551707 is a Phase 2 study of Rheumatoid Arthritis that has completed, run by Zalicus. The registered enrollment target is 51 participants, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 16 states.

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The verdict

NCT00551707, a Phase 2 study of Rheumatoid Arthritis, has completed, sponsored by Zalicus.

COMPLETED
Registry status
Phase 2
Development phase
51 participants
Enrollment target
20
Study locations

Study 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 Studied

Rheumatoid Arthritis

Interventions

  • DRUG placebo
  • DRUG CRx-102 (2.7/180)
  • DRUG prednisolone
  • DRUG dipyridamole
  • DRUG CRx-102 (2.7/360)

Study Locations (20)

California

  • - Anaheim
  • - La Jolla
  • - Westlake Village

Alabama

  • - Birmingham
  • - Huntsville

Other

  • - San Jan
  • - San Miguel de Tucumán

Arizona

  • - Phoenix

Arkansas

  • - Little Rock

Florida

  • - Palm Harbor

Kentucky

  • - Elizabethtown

New Jersey

  • - Haddon Heights

Trial Details

FieldValue
Enrollment Target 51 participants
Start Date 2007-10
Est. Completion 2009-01
Phase Phase 2

Sponsor

Zalicus

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00551707

The ClinicalTrials.gov registry entry for NCT00551707 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (99% lower). The listed sponsor is Zalicus, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 5 interventions - of which placebo is the first listed.

NCT00551707 reports 20 study locations spanning 16 distinct geographic areas - top geographies include California, Alabama, Other.

Frequently Asked Questions

What is clinical trial NCT00551707 about?

NCT00551707 is a clinical study titled "Multicenter Study to Evaluate CRx-102 vs. Each of Its Components to Treat Active Rheumatoid Arthritis". 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 immunomodu...

What is the current status of trial NCT00551707?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2007-10. Estimated completion is 2009-01.

What conditions does trial NCT00551707 study?

This clinical trial studies the following conditions: Rheumatoid Arthritis.

What interventions are being tested in trial NCT00551707?

The interventions under investigation include: placebo (DRUG), CRx-102 (2.7/180) (DRUG), prednisolone (DRUG), dipyridamole (DRUG), CRx-102 (2.7/360) (DRUG).

Who is sponsoring clinical trial NCT00551707?

This trial is sponsored by Zalicus, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00551707 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.