A Study Comparing CRx-102 Plus Disease-Modifying Anti-Rheumatic Drug (DMARD) Therapy to Placebo Plus DMARD Therapy in Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by:
Zalicus
ClinicalTrials.gov Identifier:
NCT00747214
First received: September 3, 2008
Last updated: September 8, 2008
Last verified: September 2008
  Purpose

This study was a Multicenter, Randomized, Blinded Study Comparing the Effect of CRx-102 Plus DMARD Therapy to that of Placebo Plus DMARD Therapy on Serum C Reactive Protein (CRP) and Cytokines in Subjects with Rheumatoid Arthritis. This Phase II, 6-week blinded study was planned for 60 subjects with moderate to severe rheumatoid arthritis (RA).


Condition Intervention Phase
Rheumatoid Arthritis
Other: CRx-102 plus DMARD therapy
Other: Placebo plus DMARD therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Blinded Study Comparing the Effect of CRx-102 Plus DMARD Therapy to That of Placebo Plus DMARD Therapy on Serum C Reactive Protein (CRP) and Cytokines in Subjects With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Zalicus:

Primary Outcome Measures:
  • To compare the response of CRx-102 plus disease-modifying anti-rheumatic drug (DMARD) therapy with placebo plus DMARD therapy in lowering CRP levels in rheumatoid arthritis (RA) subjects. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the changes in inflammatory cytokines in subjects treated with CRx-102 plus DMARD therapy compared with placebo plus DMARD therapy. [ Time Frame: 6 weels ] [ Designated as safety issue: Yes ]
  • To evaluate the efficacy of CRx-102 plus DMARD therapy compared with placebo plus DMARD therapy using the American College of Rheumatology (ACR) 20 and disease activity score (DAS28) indices as well as fatigue scales. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: November 2004
Study Completion Date: November 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
CRx-102 plus DMARD therapy
Other: CRx-102 plus DMARD therapy
Placebo Comparator: 2
Placebo plus DMARD therapy
Other: Placebo plus DMARD therapy
Placebo plus DMARD Therapy

Detailed Description:

The primary objective of this study was to:

• Compare the response of CRx-102 plus DMARD therapy to placebo plus DMARD therapy in lowering CRP levels in rheumatoid arthritis subjects.

The secondary objectives of this study were to:

  • Evaluate the changes in inflammatory cytokines in subjects treated with CRx-102 plus DMARD therapy to placebo plus DMARD therapy.
  • Evaluate the efficacy of CRx-102 plus DMARD therapy to placebo plus DMARD therapy using ACR-20 and DAS28 indices as well as fatigue scales.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Was 18 years of age of older
  • Had moderate to severe RA
  • Had at least 3 swollen joints (maximum 28) and 3 tender joints (maximum 28)
  • Had a Baseline CRP level of at least 2.2 mg/L and a DAS28 score >4.5
  • Had been on DMARD therapy for at least 3 months and have been on a stable dose of DMARD therapy for at least 28 days prior to enrollment
  • Had a negative pregnancy test (females)
  • Was not taking glucocorticoids at screening

Exclusion Criteria:

  • Female subject is pregnant or lactating or of child bearing potential not using acceptable methods of birth control (barriers or abstinence). Female subjects using hormonal birth control are not to be enrolled.
  • Subject is currently taking any steroids (glucocorticoids). All glucocorticoids must be discontinued for at least one month prior to entering study. Intraarticular, intramuscular, or intravenous glucocorticoids must not have been given at least 6 weeks prior to entering the study.
  • Subject is currently taking more than 81 mg of aspirin daily.
  • Subject is currently taking a statin, unless she/he has been on a stable dose of the same statin for at least 3 months prior to entering into the trial.
  • Subject has any active infections or recent surgical procedures within 30 days of study initiation.
  • Subject has uncontrolled diabetes mellitus as defined by a HbA1C value ≥ 7.0%.
  • Subject knowingly has HIV or Hepatitis.
  • Subject has undergone administration of any investigational drug within 30 days of study initiation.
  • Subject has a history of hypersensitivity to steroids and/or dipyridamole.
  • Subject has limited mental capacity or language skills such that simple instructions cannot be followed or information regarding adverse events cannot be provided.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Geri Lyons, CombinatoRx, Inc.
ClinicalTrials.gov Identifier: NCT00747214     History of Changes
Other Study ID Numbers: CRx-102-002
Study First Received: September 3, 2008
Last Updated: September 8, 2008
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Estonia: The State Agency of Medicine

Keywords provided by Zalicus:
Rheumatoid Arthritis
RA
DMARD
CRP

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014