A Phase 2, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 60mg of MM-093 Versus Placebo in Patients With Active Rheumatoid Arthritis on Stable Doses of Methotrexate

Merrimack Pharmaceuticals20 sites in 1 country100 target enrollmentFebruary 2007

InterventionsMM-093

Overview

The purpose of this study is to determine whether MM-093 is safe and effective in the treatment of RA.

To evaluate the safety and tolerability of 60 mg of MM-093 in patients who have active RA despite MTX background therapy.

Registry

clinicaltrials.gov

Start Date

February 2007

End Date

TBD

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

•Meet American College of Rheumatology (ACR) criteria for RA.
•Have active RA consisting of \> or equal to 6 tender joints and \> or equal to 6 swollen joints and one of the following:CRP or ESR levels of ULN
•Have an ACR functional class of I-III.
•Have had RA for at least 6 months.
•Had disease onset at \> 16 years of age.
•Aged 18 - 80 years.
•Currently being treated with a stable, well tolerated weekly dose of MTX between 10-25 mg for at least 6 consecutive prior to screening visit.
•Currently being treated with folic/folinic acid in conjunction with their MTX treatment.
•(Note: Patients may begin folic/folinic acid treatment after their screening visit, but must remain on stable dose for two weeks before undergoing the Day 1 assessments.)
•Willing to remain on a constant, weekly dose of MTX and folic/folinic acid through out the duration of the study.

•Patient will be excluded if any of the following prior medications are currently being used or have used within the designated time interval before the screening visit:
•Any B - cell or antibody depleting therapy , including plasmaphoresis or Prosorba columns (6 months)
•Leflunomide, Adalimumab (Humira)(3 months)
•Investigational biologics (2 months)
•Infliximab (Remicade) (2 months)
•Cyclosporine, sulphasalazine, auranofin, intramuscular gold, azathioprine, D-penicillamine, tacrolimus (6 weeks)
•Investigational small molecules (e.g. NSAIDS or Cox-2 inhibitors)(4 weeks)
•Use more than 10mg/day of prednisone or equivalent (4 weeks)
•Bolus intramuscular/intravenous (IM/IV) treatment with corticosteroids (\>20 mg prednisone or equivalent)(4 weeks)
•Intra-articular corticosteroid injection (4 weeks)