A randomized, single-blind, placebo controlled, parallel-group study evaluating the anti-inflamatory activity of GSK315234 in synovial biopsy tissue obtained from subjects with rheumatoid arthritis (OSM105196)

Phase 2

• Conditions: Rheumatoid arthritis; 10023213

• Registration Number: NL-OMON34936
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

* Males and females, 18-75 years.
* Reumatoid arthritis (ACR criteria).
* Inflamed ankle or knee.
* DAS28>3.2.
* CRP>0.5 mg/dl.
* BMI 18.5-35 kg/m2.
* No treatment failure (efficacy) on biological in the past.
* At least 3 months on stable methotrexaat dose, up to 25 mg/week.
* At least 3 months on stable folate suppletion, at least 5 mg/week.
* Treatment with sulfasalazin, (OH)chloroquin, NSAIDs, oral and i.m. glucocorticosteroids conditionally accepted (for conditions, see protocol).
* Adequate anticonceptie voor vrouwen die kinderen kunnen krijgen en voor mannen.

Exclusion Criteria

* Hepatitis B-C.
* Immuundeficiency.
* Prior exposure to or infection with mycobacterium tuberculosis, unless adequately treated.
* Acute infection.
* Creatinin clearance < 50 ml/min.
* Cyclosporin, leflonomid, cyclophosphamid, azathioprin, gold, d-penicillamine or intra-articular glucocorticosteroids in the month prior to screening.
* Rituximab or comparable.
* Live vaccinaton in the past 3 months.
* Zwangerschap en borstvoeding tijdens gebruik van studiemedicatie.
* Bleeding disorders, anaemia, peptic ulcer, GI bleeding in the past 6 months.
* Vitamin B12 or folate deficiency in anamnesis.
* Haematological disease or acquired platelet disease.
* Known increased risk for intra-cranial bleeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Biomarkers for inflammation in synovial tissue, adverse events. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Changes in bone and synovium parameters (MRI), systemic biomarkers, clinical<br /><br>efficacy, PK/PD, immunogenicity.</p><br>