Rheumatoid Arthritis Clinical Trial
Official title:
A Phase I/II, Open Label, Dose Ranging Study of the Safety, Tolerance, Pharmacokinetics and Potential Anti-Inflammatory Activity of HE3286 When Administered Orally for 29 Days to Patients With Rheumatoid Arthritis on a Stable Dose of Methotrexate
Verified date | June 2011 |
Source | Harbor Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this pilot, exploratory study is to evaluate the safety, tolerance, pharmacokinetics and potential anti-inflammatory activity of an investigational agent, HE3286, when administered orally for 29 days to patients with rheumatoid arthritis that are taking a stable dose of methotrexate.
Status | Completed |
Enrollment | 14 |
Est. completion date | July 2009 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Main Inclusion Criteria: - Male or female patient 18-75 years of age - Patient with stable or active disease on a stable dose of methotrexate for at least 30 days prior to Day 1 - Patient has normal thyroid stimulating hormone (TSH) levels with or without thyroid replacement therapy - Patient is willing to abstain from consuming grapefruit containing products from 24 hours prior to dosing until the end of the study as it may affect the pharmacokinetic measurements - Patient has not experienced renal or liver disease by history and/or based on laboratory results - Patient has not experienced acute cardiac disease within 6 months prior to Screening - Patient must provide voluntary, written, informed consent prior to screening evaluations and be able to follow verbal and written instructions. Main Exclusion Criteria: - Functional status class IV according to The American College of Rheumatology (ACR) criteria - Patient who has a history of clinically significant cardiovascular disease (including coronary artery disease), clinically significant hepatic, respiratory or renal abnormalities, or clinically significant endocrine disorders (including diabetes) - Patient with active Tuberculosis (TB) or evidence of latent TB without previous adequate therapy - Systemic autoimmune disorder (including, but not limited to, systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease or any overlap syndrome) - Inflammatory joint disease other than RA - Patient who has received any of the following immunosuppressive drugs: - Etanercept within 1 month of Day 1; - Abatacept, adalimumab, infliximab, leflunomide, imuran, cyclosporin, anakinra, sulfasalazine, bextra, celebrex or gold within 2 months of Day 1 or for biological agents 6 half lives, whichever is greater; - Rituximab within 1 year of Day 1 - Patient that is bed or wheelchair bound - Patients taking prednisone within 2 weeks prior to Screening - Patient requiring or receiving any of the following within thirty (30) days prior to the screening visit: interleukins, steroids (i.e., anabolic steroids, glucocorticoids), hormone replacement therapy (except stable low-dose HRT for at least 6-months prior to screening), birth control pills, anti-cancer chemotherapeutic agents (except methotrexate), metabolic inhibitors (except methotrexate), concomitant medications that prolong the QT/QTc interval - Patient who has any clinically significant abnormalities in laboratory results at Screening |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Harbor Therapeutics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and pharmacokinetics | Duration of the study | ||
Secondary | To assess the potential activity of HE3286 to decrease inflammation via evaluation of inflammatory cytokine activity. | Duration of study |
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