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)

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) - OSM105196

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34936

Enrollment

Registered

2010-03-16

Start date

2010-03-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis

Interventions

Treatment with GSK315234 or placebo.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: * Hepatitis B-C. * Immuundeficiency. * Prior exposure to or infection with mycobacterium tuberculosis, unless adequately treated. * Acute infection. * Creatinin clearance

Design outcomes

Primary

Measure	Time frame
Biomarkers for inflammation in synovial tissue, adverse events.	—

Secondary

Measure	Time frame
Changes in bone and synovium parameters (MRI), systemic biomarkers, clinical efficacy, PK/PD, immunogenicity.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)