Clinical trial NCT00747214: A Study Comparing CRx-102 Plus Disease-modifying Anti-rheumatic Drug (DMARD) Therapy to Placebo Plus DMARD Therapy in RA
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 RA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
RA
DMARD
CRP
Lead sponsor: Zalicus
Sponsor class: INDUSTRY
First posted: 2008-09-05
Enrollment: 59
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: 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).

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 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.

Primary outcomes:
measure: Change in CRP From Baseline to Day 42
timeFrame: Baseline and Day 42
Secondary outcomes:
measure: Improvement of ACR 20 Scores at End of Study (Day 42/Visit 5)
timeFrame: Day 42
measure: Change in DAS28 Score From Baseline to Day 42
timeFrame: Baseline and Day 42
measure: Change in Fatigue (MAF Scale) Score From Baseline to Day 42
timeFrame: Baseline and Day 42
Other outcomes:
Locations:
Study officials:
affiliation: Zalicus
name: Margaret Lee, PhD
role: STUDY_DIRECTOR
References: