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: 13.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-28
• Last Update Posted: 19 May 2014

Recruitment & Eligibility

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

Inclusion Criteria

To be eligible for inclusion, each patient must fulfill the following 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:
o C-reactive protein > 1.0 mg/dl at screening;
o 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;
o 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
• Patients must have voluntarily signed the informed consent form.

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

Patients are not eligible for this study if they fulfill one or more of the following criteria:
• Patients who received previous therapy with any biologic agent;
• Patients currently taking any disease modifying anti-rheumatic drug (DMARD) other than MTX;
o Previous non-biologic DMARD therapy is permitted as long as their last dose was at least 28 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 who are 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;
o Patients with a serum creatinine level > 1.5 mg/dl at screening;
o 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.

Study & Design

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