A Study to Assess CH1504 in Patients With Active Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00658047
• Date of registration: 08/04/2008
• Prospective Registration: No
• Primary sponsor: Chelsea Therapeutics
• Public title: A Study to Assess CH1504 in Patients With Active Rheumatoid Arthritis CH-1504-201
• Scientific title: A Phase II, Multi-center, Randomized, Double-blind, Methotrexate Controlled Study to Assess the Clinical Efficacy, Safety, and Tolerability of CH-1504 in Subjects With Active Rheumatoid Arthritis
• Date of first enrolment: April 2008
• Target sample size: 201
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00658047
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Canada

Contacts

• Name: Edward Keystone, MD
• Affiliation: The Rebecca MacDonald Centre for Arthritis and Autoimmune Disease

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Arthritis, Rheumatoid

Intervention(s)

Drug: CH-1504

Drug: Methotrexate (MTX)

Primary Outcome(s)

Assess the clinical effect of CH-1504 (0.25, 0.5, and 1.0 mg po daily) by determining the proportion of patients achieving an ACR20 response. [Time Frame: 3 months of treatment]

Secondary Outcome(s)

Assess the clinical efficacy of CH-1504 using EULAR "good" and "moderate" response criteria. [Time Frame: 3 months of treatment]

Assess the clinical efficacy of CH-1504 by proportion of patients achieving ACR50 and ACR70 responses. [Time Frame: 3 months of treatment]

Identify the dose response relationship of CH-1504. [Time Frame: 3 months of treatment]

Evaluate the safety and tolerability of CH-1504 in RA patients as determined by the frequency and severity of adverse events, laboratory abnormalities, and dropouts. [Time Frame: 3 months of treatment]

Assess the clinical efficacy of CH-1504 using the difference from baseline of ACR core set and DAS28 of measures. [Time Frame: 3 months of treatment]

Secondary ID(s)

CH-1504-201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors