A Study Comparing CRx-102 Plus Disease-modifying Anti-rheumatic Drug (DMARD) Therapy to Placebo Plus DMARD Therapy in RA
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: CRx-102; Placebo; DMARD Therapy
Intervention description: DMARD therapy can include methotrexate or other DMARD therapy
Intervention MeSH terms: Prednisolone; Antirheumatic Agents; Dipyridamole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; RA; DMARD; CRP

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).
    

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.