A Study Comparing CRx-102 Plus Disease-modifying Anti-rheumatic Drug (DMARD) Therapy to Placebo Plus DMARD Therapy in RA

NCT00747214 | Completed Phase 2 Results

• 1 other identifier: CRx-102-002
• Study Type: interventional
• Target: 59
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; RA; DMARD; CRP

Outcome Measures

Primary Outcomes (1)

• Change in CRP From Baseline to Day 42

  The primary efficacy variable in this study was the change in CRP from Baseline (Day 1/Visit 2) to End of Study (Day 42/Visit 5). Blood samples for the analysis of serum CRP were taken at each visit.

  Baseline and Day 42

Secondary Outcomes (3)

• Improvement of ACR 20 Scores at End of Study (Day 42/Visit 5)

  Day 42

• Change in DAS28 Score From Baseline to Day 42

  Baseline and Day 42

• Change in Fatigue (MAF Scale) Score From Baseline to Day 42

  Baseline and Day 42

Study Arms (2)

CRx-102 plus DMARD therapy

EXPERIMENTAL

Drug: CRx-102; Drug: DMARD Therapy

Placebo plus DMARD therapy

PLACEBO COMPARATOR

Drug: Placebo; Drug: DMARD Therapy

Interventions

CRx-102 DRUG

Also known as: Prednisolone plus dipyridamole

CRx-102 plus DMARD therapy

Placebo DRUG

Also known as: sugar pill

Placebo plus DMARD therapy

DMARD Therapy DRUG

DMARD therapy can include methotrexate or other DMARD therapy

Also known as: Disease modifying anti-rheumatic drug therapy

CRx-102 plus DMARD therapy; Placebo plus DMARD therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zalicus: lead

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

dipyridamole, prednisolone drug combination; Prednisolone; Dipyridamole; Sugars

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbohydrates

Results Point of Contact

• Title: Margaret Lee, PhD
• Organization: Zalicus

mlee@zalicus.com

617-301-7142

Study Officials

• Margaret Lee, PhD

  Zalicus

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2008
• First Posted: September 5, 2008
• Study Start: November 1, 2004
• Primary Completion: September 1, 2006
• Study Completion: November 1, 2006
• Last Updated: May 20, 2014
• Results First Posted: May 20, 2014

Record last verified: 2014-04