Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis RA DMARD CRP
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 59
Healthy volunteers: no

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.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: CRx-102 intervention 2: Placebo intervention 3: DMARD Therapy
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: DMARD therapy can include methotrexate or other DMARD therapy

Protocol document: