A Randomized, Double-blind, Placebo-controlled Clinical Study of the Oral IL-12/23 Inhibitor, STA-5326 Mesylate, Administered to Patients With Rheumatoid Arthritis to Determine Safety, Tolerability, Pharmacokinetic and Synovial Tissue Outcomes
February 3, 2014 updated by: Synta Pharmaceuticals Corp.
It is not fully clear how rheumatoid arthritis originates and develops, but it is understood that multiple genetic and environmental factors interact to trigger its onset.
The immune system attacks the joint synovium, which damages the cartilage and bone in the joint by increasing the number of inflammatory cells and forming new blood vessels in the joint space.
STA-5326 mesylate inhibits the production of IL-12 and IL-23 and therefore may inhibit Th-1 cytokine production.
A reduction in the Th-1 response has the potential to minimize or eliminate joint damage caused by the immune response in rheumatoid arthritis.
This study is designed to assess whether the proposed mechanism of action is associated with a reduction in inflammation in the synovium of patients who have rheumatoid arthritis.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
35
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Amsterdam, Netherlands
- Academic Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female 18 years of age or older.
- Has a diagnosis of RA in conformance with the American College of Rheumatology (ACR) criteria for at least 6 months.
- Has at least one knee, wrist, or ankle that has active synovitis and is amenable to arthroscopic procedures for the acquisition of synovial tissue via biopsy.
- Must be taking methotrexate for a minimum of 4 months prior to Day 1, with a stable dose regimen for at least 2 months, and
- have plans to remain on the stable dose regimen of methotrexate for the duration of this study.
- If female of childbearing potential, must be neither pregnant nor breast feeding, and
- must have a negative pregnancy test (serum β-hCG) within 1 week of Day 1. Must be willing to use "double-barrier" contraception methods for the duration of the study.
Exclusion Criteria:
- Is taking any disease-modifying anti-rheumatic drug (DMARD) other than MTX concomitantly or within 1 month prior to Day 1.
- A positive (≥10 mm) tuberculin (PPD) skin test, unless the patient has had prior BCG immunization or has received prior suppressive treatment such as 1 year of INH.
- Has received any investigational drug or experimental procedure for the treatment of RA within 3 months of Day 1 for a biologic compound or within 1 month of Day 1 for a non-biologic compound.
- Has any clinically significant disease (e.g., renal, hepatic, neurological, cardiovascular, pulmonary, endocrine, psychiatric, hematologic, urologic, or other acute or chronic illness) that, in the opinion of the investigator, would make the patient an unsuitable candidate for this trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Placebo Comparator: 2
Placebo
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Placebo taken orally twice a day for 8 weeks with the option to continue at the same dose and frequency for an additional 4 weeks.
|
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Active Comparator: 1
STA-5326 mesylate
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STA 5326 mesylate 100mg taken orally twice a day for 8 weeks with the option to continue at the same dose and frequency for an additional 4 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2005
Study Registration Dates
First Submitted
March 20, 2008
First Submitted That Met QC Criteria
March 24, 2008
First Posted (Estimate)
March 25, 2008
Study Record Updates
Last Update Posted (Estimate)
February 4, 2014
Last Update Submitted That Met QC Criteria
February 3, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5326-09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.