A Study of CH-4051 in Patients With Rheumatoid Arthritis (RA)

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if CH-4051 is a safe and effective treatment for rheumatoid arthritis.

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

Details

• Lead Sponsor: Chelsea Therapeutics
• Treatments: Folic Acid; Methotrexate; Vitamin B Complex

Criteria

Inclusion Criteria:

• Patients must be between the ages of 18 and 80;

• Have diagnosed active rheumatoid arthritis according to ACR criteria functional class I-III;

• Have at least 6 swollen joints (max = 66) and 6 tender joints (max = 68) at screening and baseline visits;

• Patients must have at least one of the following:

• C-reactive protein > 1.0 mg/dl at screening;

• erythrocyte sedimentation rate > 28 mm/Hr;

• Patients must have been taking methotrexate between 15 and 25 mg/week for at least 3 months and at a stable dose for at least 6 weeks;

• Patients must be either Rheumatoid Factor (RF) or anti-cyclic citrullinated peptide (anti-CCP) positive;

• Patients must have voluntarily signed the informed consent.

Exclusion Criteria:

• Patients who received previous therapy with any biologic agent;

• Patients currently taking any disease modifying anti-rheumatic drug (DMARD) other than MTX;

• Previous non-biologic DMARD therapy is permitted as long as their last dose was at least 30 days prior to baseline;

• Female patients of child bearing potential who are pregnant or who are not using two methods of contraception (at least one barrier: i.e. condom) with their partner;

• Male patients who are sexually active and not using two methods of contraception (at least one barrier: i.e. condom) with their partner;

• Patients with any current active infection or infections requiring IV drug therapy within 30 days of baseline or oral therapy within 15 days of Baseline;

• Patients that have had any surgical procedures within 30 days of baseline;

• Patients with a history of HIV;

• Patients with Hepatitis B surface antigen positive and/or Hepatitis C antibody positive;

• Patients who consume more than 4 units of alcohol per week (1 unit = 5 ounces/150 ml of wine = 1.5 ounces/45 ml spirits = 12 ounces/360 ml of beer);

• Patients currently receiving any investigational drug or have received an investigational drug within 30 days of baseline or 5 half-lives of the investigational drug (whichever is longer);

• Patients with a history of cancer within the past 5 years other than a successfully treated, non-metastatic cutaneous squamous cell or basal cell carcinoma or cervical cancer in situ;

• Patients with a history of, or any, disease associated with an inflammatory arthritis other than RA;

• Patients with pulmonary fibrosis (Chest x-ray must be taken within 28 days of screening);

• Patients receiving probenecid;

• Patients who have received any steroid injections within 30 days of baseline;

• Patients with concomitant diseases that are unstable (i.e. cardiac, pulmonary) or that may affect drug activity (i.e. absorption, reactions, change in kinetics);

• Patients, in the investigator's opinion, that have any significant renal or hepatic impairment;

• Patients with a serum creatinine level > 1.5 mg/dl at screening;

• Patients with an ALT >1.5 ULN at screening;

• Patients considered by the investigator to be an unsuitable candidate to receive CH-4051;

• Wheelchair or bed-bound patients.