A Study of CH-4051 in Patients With Rheumatoid Arthritis (RA)

NCT01116141 | Completed Phase 2 DMC

• 1 other identifier: CH-4051-RA202
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine if CH-4051 is a safe and effective treatment for rheumatoid arthritis.

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis; MTX; CH-405; antifolates

Outcome Measures

Primary Outcomes (1)

• Co-primary: Hybrid American College of Rheumatology response criteria (hACR)followed by the ACR20

  The hybrid ACR (hACR) response was developed by the American College of Rheumatology to provide an improvement measure more sensitive to change than many other currently used measures, e.g., traditional ACR 20, 50 and 70 responses, while still maintaining clinical meaning. While traditional ACR 20, 50 and 70 response criteria are dichotomous measures (responder = yes/no), the hACR is a semi-continuous variable based upon the traditional ACR response but incorporating additional information on patient response into the outcome measure.

  12 weeks

Secondary Outcomes (4)

• DAS28

  12 weeks

• ACR response criteria

  12 weeks

• Morning stiffness

  12 weeks

• 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

  12 weeks

Study Arms (5)

Methotrexate (MTX) + Folic Acid

ACTIVE COMPARATOR

20 mg MTX weekly + 1 mg folic acid daily

Drug: Methotrexate (MTX); Drug: Folic Acid

0.3 mg CH-4051

EXPERIMENTAL

0.3 mg CH-4051 daily

Drug: CH-4051

1.0 mg CH-4051

EXPERIMENTAL

1.0 mg CH-4051 daily

Drug: CH-4051

3.0 mg CH-4051

EXPERIMENTAL

3.0 mg CH-4051 daily

Drug: CH-4051

3.0 mg CH-4051 + folic acid

EXPERIMENTAL

3.0 mg CH-4051 + 1.0 mg folic acid daily

Drug: CH-4051; Drug: Folic Acid

Interventions

CH-4051 DRUG

Different doses CH-4051 to be compared

0.3 mg CH-4051; 1.0 mg CH-4051; 3.0 mg CH-4051; 3.0 mg CH-4051 + folic acid

Methotrexate (MTX) DRUG

20 mg MTX weekly

Also known as: amethopterin

Methotrexate (MTX) + Folic Acid

Folic Acid DRUG

1 mg folic acid daily

Also known as: folate

3.0 mg CH-4051 + folic acid; Methotrexate (MTX) + Folic Acid

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• C-reactive protein \> 1.0 mg/dl at screening;
• 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;
• Patients must have voluntarily signed the informed consent.

You may not qualify if:

• Patients who received previous therapy with any biologic agent;
• Patients currently taking any disease modifying anti-rheumatic drug (DMARD) other than MTX;
• Previous non-biologic DMARD therapy is permitted as long as their last dose was at least 30 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 with 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;

Sponsors & Collaborators

• Chelsea Therapeutics: lead

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Methotrexate; Folic Acid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Arthur A Kavanaugh, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2010
• First Posted: May 4, 2010
• Study Start: September 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: May 1, 2012
• Last Updated: April 15, 2013

Record last verified: 2013-04