A Study to Assess CH1504 in Patients With Active Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to assess the clinical effect of CH-1504 at doses of 0.25, 0.5 and 1.0 mg per day in patients with active rheumatoid arthritis by determining the proportion of patients achieving an American College of Rheumatology (ACR) 20% improvement response.

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

Details

• Lead Sponsor: Chelsea Therapeutics
• Treatments: Aminopterin; Methotrexate

Criteria

Inclusion; To be eligible for inclusion, each patient must fulfill the following criteria:

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

• Have been diagnosed with active rheumatoid arthritis according to ACR criteria;

• 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 > 20 mm/Hr;

• Morning stiffness > 45 min. at screening;

• Patients must have blood test values per the following criteria:

• ALT, AST < 1.2 U/l x ULN

• Albumin > 2.5 g/dl

• Prothrombin Time < 1.2 INR

• Hb > 9.0 g/dl

• Hct > 35%

• WBC > 3000 μl (mm3)

• Neutrophils > 1000 μl (mm3)

• Platelets > 100000 μl

• Creatinine < 1.2 mg/dl

• Patients must have voluntarily signed the informed consent

Exclusion; Patients are not eligible for this study if they fulfill one or more of the following criteria:

• Patients who received previous methotrexate therapy;

• Patients who received previous therapy with any biologic agent;

• Previous biologic therapy for a disease other than RA is permitted so long as their last dose was more than 120 days prior to baseline;

• Patients currently taking sulfasalazine;

• Previous sulfasalazine therapy is permitted so long as their last dose was more than 30 days prior to baseline;

• Patients currently taking hydroxychloroquine;

• Previous hydroxychloroquine is permitted so long as their last dose was more than 120 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, Hepatitis B or C;

• Patients who consume more than 7 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 a chest X-ray that indicates the presence of pulmonary fibrosis (Chest x-ray may be taken with in 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 considered by the investigator to be an unsuitable candidate to receive CH-1504;

• Wheelchair or bed-bound patients.