Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 When Added to Methotrexate

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the efficacy (ACR20) of Rob 803 administered orally once daily for 12 weeks in combination with a stable dose of methotrexate in subjects with moderate or severe active RA.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OxyPharma
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

• Diagnosed with RA based on the ARA 1987 revised criteria at least 16 weeks prior to study enrolment, Day 0

• Have an ACR global functional status class of 1 to 3

• Have active disease, defined as the presence of 6 swollen joints and 6 tender joints in a 44 joint examination

• Have a CRP level at screening of ≥ 1.5 mg/dL

• Have been taking oral or parenteral methotrexate (15 mg weekly or above), have been using methotrexate for at least 16 weeks (up to Day 0 of study), and have been on a stable dose for at least 8 weeks, up to Day 0.

Exclusion Criteria:

• Arthritis onset prior to 16 years old

• Any of the following infections:

• Known or acute infection that may affect CRP levels

• Active tuberculosis

• Known chronic infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV) including positive serology

• Ongoing systemic inflammatory condition which may interfere with the results of clinical or laboratory tests planned in the study (eg, systemic lupus erythematosus or any other systemic rheumatic disease other than RA)