Status:
COMPLETED
A Study to Assess CH1504 in Patients With Active Rheumatoid Arthritis
Lead Sponsor:
Chelsea Therapeutics
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 ac...
Detailed Description
Rheumatoid Arthritis (RA) is a chronic inflammatory disease of unknown cause that leads to pain, stiffness, swelling and limitation of joint function. If left untreated, RA produces serious destructio...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT00658047
Start Date
April 1 2008
End Date
June 1 2009
Last Update
April 15 2013
Active Locations (1)
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1
The Rebecca MacDonald Centre for Arthritis and Autoimmune Disease
Toronto, Ontario, Canada, M5G 1X5