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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 19 May 2014
Main ID:  EUCTR2010-019134-27-CZ
Date of registration: 28/06/2010
Prospective Registration: Yes
Primary sponsor: Chelsea Therapeutics, Inc
Public title: 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
Scientific title: 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
Date of first enrolment: 19/10/2010
Target sample size: 250
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-019134-27
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no  
Phase: 
Countries of recruitment
Bulgaria Czech Republic
Contacts
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Key inclusion & exclusion criteria
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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Rhuematoid Arthritis
MedDRA version: 13.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Intervention(s)

Product Name: CH-4051
Product Code: CH-4051
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Dipotassium Salt
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.3-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Product Name: CH-4051
Product Code: CH-4051
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Dipotassium Salt
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.0-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Product Name: CH-4051
Product Code: CH-4051
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Dipotassium Salt
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3.0-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Trade Name: Methotrexate
Product Name: Methotrextate
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Methotrexate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Trade Name: Folic Acid
Product Name: Folic Acid
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Folic Acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-

Primary Outcome(s)
Main Objective: Demonstrate clinical efficacy of one or more doses of CH-4051 (0.3 mg, 1.0 mg, 3.0 mg and 3.0 mg with 1 mg folic acid supplementation p.o. daily) compared to MTX (20 mg/week) with 1.0 mg of folic acid supplementation p.o. daily as measured by the Hybrid ACR score, followed in a hierarchical step-down analysis of the Proportion of patients achieving ACR20.
Primary end point(s): The hACR will be summarized at each visit. A one-way analysis of variance (ANOVA) will be employed to assess treatment effect at Week 12. Each of the CH-4051 treatments will be compared to the MTX. Any changes between Weeks 12 and 16 will be noted.

The co-primary end point, ACR20 will be analyzed using a “gatekeeper” function only if the hACR endpoint reaches statistical significance (p< 0.05). The ACR20 will be summarized at each visit. Differences between groups at week 12 will be compared using a Pearson’s Chi-squared test. Any changes between Weeks 12 and 16 will be noted. Details will be provided in the SAP.
Secondary Objective: • Assess the clinical efficacy of CH-4051 using DAS28 scores;
• Assess the clinical efficacy of CH-4051 through analyses of the Area Under the Curve (AUC) of the Hybrid and DAS28 scores;
• Proportion of patients achieving ACR50 and ACR70 response;
• Assess the clinical efficacy of CH-4051 through analyses of the Area Under the Curve (AUC) of the ACR20, 50 and 70;
• Assess linear trends in the Hybrid ACR, DAS28 and ACR20 scores across dose groups;
• Assess the clinical efficacy of CH-4051 using EULAR “good” and “moderate” response criteria;
• Assess the clinical efficacy of CH-4051 using mean changes from baseline in the components of the ACR and DAS28 response criteria;
• Assess the clinical efficacy of CH-4051 using mean change from baseline of morning stiffness;
• Evaluate the safety and tolerability of CH-4051 in RA patients as determined by the frequency and severity of adverse events, laboratory abnormalities, and dropouts due to AEs.
Secondary Outcome(s)
Secondary ID(s)
CH-4051-RA202
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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