A PHASE II, MULTI-CENTER, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND, METHOTREXATE CONTROLLED STUDY TO ASSESS THE CLINICAL EFFICACY, SAFETY, AND TOLERABILITY OF CH-4051 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE SHOWN AN INADEQUATE RESPONSE TO METHOTREXATE MONOTHERAPY

• Conditions: Rhuematoid Arthritis; MedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

• Registration Number: EUCTR2010-019134-27-BG
• Lead Sponsor: Chelsea Therapeutics, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-18
• Last Update Posted: 5 November 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

To be eligible for inclusion, each patient must fulfill the following criteria:
1. Patients must be between the ages of 18 and 80;
2. Have diagnosed active rheumatoid arthritis according to ACR criteria functional class I-III;
3. Have at least 6 swollen joints (max = 66) and 6 tender joints (max = 68) at screening and baseline visits;
4. Patients must have at least one of the following:
a. C-reactive protein > 1.0 mg/dl at screening;
b. erythrocyte sedimentation rate > 28 mm/Hr;
5. 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;
6. Patients must be either Rheumatoid Factor (RF) or anti-cyclic citrullinated peptide (anti-CCP) positive;
a. Patients that are not RF or Anti-CCP positive may be entered into the study only after consultation with and approval by the Medical Monitor
7. Patients must have voluntarily signed the informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients who received previous therapy with any biologic agent;
2. Patients currently taking any disease modifying anti-rheumatic drug (DMARD) other than MTX;
a. Previous non-biologic DMARD therapy is permitted as long as their last dose was at least 28days prior to baseline;
3. 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;
4. Male patients who are sexually active and not using two methods of contraception (at least one barrier: i.e. condom) with their partner;
5. 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;
6. Patients that have had any surgical procedures within 30 days of baseline;
7. Patients with a history of HIV;
8. Patients with Hepatitis B surface antigen positiveand/or Hepatitis C antibody positive;
9. 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);
10. 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);
11. 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;
12. Patients with a history of, or any, disease associated with an inflammatory arthritis other than RA;
13. Patients with pulmonary fibrosis (Chest x-ray must be taken within 28 days of screening);
14. Patients receiving probenecid;
15. Patients who have received any steroid injections within 30 days of baseline;
16. Patients with concomitant diseases that are unstable (i.e. cardiac, pulmonary) or that may affect drug activity (i.e. absorption, reactions, change in kinetics);
17. Patients, in the investigator’s opinion, that have any significant renal or hepatic impairment;
a. Patients with a serum creatinine level > 1.5 mg/dl at screening;
b. Patients with an ALT >1.5 ULN at screening;
18. Patients considered by the investigator to be an unsuitable candidate to receive CH-4051;
19. Wheelchair or bed-bound patients.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified