Birmingham, AL, September 18, 2012 --(PR.com
)-- Rheumatoid Arthritis (RA) is a chronic systemic inflammatory autoimmune disease that targets the synovial tissues. The synovial inflammation may cause irreversible cartilage destruction and erosion of bone. The goal of RA treatment is to arrest the disease and achieve remission by preventing or controlling joint damage, preventing loss of function, and relieving pain, thereby improving patient quality of life.
Treatment of Rheumatoid Arthritis now focuses on early, aggressive use of effective agents to halt disease progression and prevent joint destruction. As a result, clinicians are initiating and emphasizing treatment with traditional disease-modifying antirheumatic drugs (DMARDs) and biologics earlier in the treatment paradigm.
Planned Total Number of Study Centers and Location
Approximately 35 centers worldwide
Design & Methodology
This is a Phase 2b, randomized, double-blind, parallel-group, placebo controlled, dose-finding, monotherapy, multi-center study with once daily (QD) oral Rheumatoid Arthritis drug or matching placebo in subjects with moderate to severe Rheumatoid Arthritis (RA). Potential subjects who have previously used or are currently using a DMARD may be eligible to participate provided the specified protocol criteria are met.
Subjects will be randomized in an equal ratio to receive one of the following:
1. [New Rheumatoid Arthritis Drug] 25 mg once a day (QD)
2. [New Rheumatoid Arthritis Drug] 50 mg once a day (QD)
3. [New Rheumatoid Arthritis Drug] 100 mg once a day (QD)
4. [New Rheumatoid Arthritis Drug] 150 mg once a day (QD)
5. [New Rheumatoid Arthritis Drug] Placebo
Subjects in each treatment group will take this new Rheumatoid Arthritis drug or matching placebo, taken orally with or without food, daily for 12 weeks after randomization. The first dose will be taken on Baseline/Day 1 of the treatment period at the site.
Potential subjects who have previously used DMARDs, may be eligible to participate provided the following washout periods are met:
Oral DMARDs – 28 days
Etanercept – 28 days
Certolizumab, adalimumab, golimumab, infliximab, and tocilizumab – 60 days
Rituximab – 180 days
Abatacept – 90 days
Anakinra – 7 days
Trough plasma pharmacokinetic (PK) samples will be collected from each subject prior to the daily dose of study drug at each visit during the Treatment period.
Whole blood pharmacodynamic (PD) samples will be collected from each subject at Baseline/Day 1, Week 2/Day 15, Week 4/Day 29 (biomarkers only) and Week 12/EOT.
An independent Data and Safety Monitoring Board (DSMB) will be organized to assess, at intervals, the progress of the clinical trial and the safety data, and to make recommendations to the sponsor whether to continue, modify or stop the trial.
Subjects who consent to participate in the optional pharmacogenomics substudy will have a blood sample collected during the baseline visit, after randomization but prior to the first dose of study drug, and stored for exploratory retrospective pharmacogenomics (PGx) analysis.
Subject is eligible for the study if all of the following apply:
1. Institutional Review Board (IRB) / Independent Ethics Committee (IEC) approved written Informed Consent and privacy language as per national regulations (e.g., HIPAA Authorization for U.S. sites) must be obtained from the Subject or legally authorized representative prior to any study related procedures (including withdrawal of prohibited medication, if applicable).
2. Male or female subject is at least 18 years of age at the time of Informed Consent.
3. Subject has RA that was diagnosed according to the 1987 revised criteria of the American College of Rheumatology (ACR); formerly, the American Rheumatism Association at least 6 months prior to Screening.
4. Subject’s other related medication taken for the treatment of RA at the time of Screening must meet the following stability requirements:
Non- steroidal anti-inflammatory drugs (NSAIDs), selective cyclooxygenase-2 (COX-2) inhibitors, and oral corticosteroids (≤ 10 mg of prednisone, or equivalent, daily) must be stable for at least 28 days prior to the start of study drug.
5. Subject has active rheumatoid arthritis as evidenced by the following:
≥6 tender/painful joints (using 68-joint assessment);
≥6 swollen joints (using 66-joint assessment); and
C-Reactive Protein (CRP) of ≥ 0.8 mg/dL or Erythrocyte Sedimentation Rate (ESR) of ≥ 28 mm/hr at Screening.
6. Subject meets the ACR 1991 Revised Criteria for Global Functional Status in RA, Class I, II or III at Screening.
7. If female of child-bearing potential, the subject must be non-pregnant, currently using investigator-approved contraception (documented) and continue to use this contraception throughout the study period.
8. Subject, if male, must agree to no sperm donation and/or must be using an adequate method of contraception throughout the study period and for 90 days after the last dose of study drug.
9. Subject must be willing and able to comply with the study requirements.
*Achieve Clinical Research conducts Clinical Research Studies in Birmingham, Alabama. For more information about getting started with a Clinical Trial, please visit our website or contact us directly at (205) 380-6434.