Full Text View
Tabular View
No Study Results Posted
Related Studies
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
This study is ongoing, but not recruiting participants.
First Received: March 20, 2008   Last Updated: March 24, 2008   History of Changes
Sponsored by: Synta Pharmaceuticals, Corp.
Information provided by: Synta Pharmaceuticals, Corp.
ClinicalTrials.gov Identifier: NCT00642629
  Purpose

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.


Condition Intervention Phase
Active, Moderate to Severe Rheumatoid Arthritis
Drug: STA 5326 mesylate
Drug: Placebo
Phase II

MedlinePlus related topics: Rheumatoid Arthritis
Drug Information available for: Apilimod mesylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Synta Pharmaceuticals, Corp.:

Estimated Enrollment: 35
Study Start Date: December 2005
Arms Assigned Interventions
1: Active Comparator
STA-5326 mesylate
Drug: STA 5326 mesylate
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.
2: Placebo Comparator
Placebo
Drug: Placebo
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00642629

Locations
Netherlands
Academic Medical Center
Amsterdam, Netherlands
Sponsors and Collaborators
Synta Pharmaceuticals, Corp.
  More Information

No publications provided

Responsible Party: Synta Pharmaceuticals ( David Hynds, Clinical Trial manager )
Study ID Numbers: 5326-09
Study First Received: March 20, 2008
Last Updated: March 24, 2008
ClinicalTrials.gov Identifier: NCT00642629     History of Changes
Health Authority: Netherlands: Independent Ethics Committee

Study placed in the following topic categories:
Interleukin-12
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:
Autoimmune Diseases
Immune System Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 07, 2009