A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA
- Conditions
- Active rheumatoid arthritisMedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2012-002181-12-IT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 178
• Subject has a diagnosis of RA for at least 6 months prior to screening. • Subject has active RA as defined by the presence of 6 swollen joints (of 66 joint count) AND 6 tender joints (of 68 joint count) at screening (Visit 1) and baseline (Visit 2). • Subject has a C-reactive protein (CRP) blood level > 0.9 mg/dL from the central reference laboratory at screening. • Subject is anti-cyclic citrullinated antibody positive and/or rheumatoid factor positive at screening. • Subject is ACR functional Class I, II, or III. • Subject must have received MTX for a minimum of 3 months prior to screening with a regionally appropriate stable weekly dose for at least 4 weeks prior to screening (15-25 mg/wk for regions outside of Asia, and 6-25 mg/week for Asia). The subject's dose of weekly MTX must remain stable through week 24 of the study. • Subject must have either failed treatment with 1 or 2 anti-TNF? therapies or was intolerant to anti-TNF?therapy prior to screening. For subjects who have failed therapy, the treatment with anti-TNF therapies must have been for at least 3 months. Note: The inadequate response or intolerance to anti-TNF therapy will be defined by the Investigator's assessment and will be recorded. Typically, an inadequate response is based on clinical reasons (e.g., no improvement or worsening of RA). Lack of access to the medication or financial reasons are not considered an inadequate response
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 158
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
• Subject has inflammatory disease other than RA, including but not limited to psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, or Lyme disease. • Previous exposure to fostamatinib or other splenic tyrosine kinase (SYK) inhibitors. • Previous exposure to any biological agents other than anti-TNF therapeutic agents, including but not limited to abatacept, tocilizumab, rituximab or other biological agents used for the treatment of RA. • Subject has received any treatment (listed in the table below) more recently than the indicated washout period prior to randomization. Washout Period for Medications Prior to Randomization Medications, Supplements, and Other Substances Washout Period Prior to Randomization Anti-TNF-a Therapies: Adalimumab Certolizumab Etanercept Golimumab Infliximab 8 weeks 8 weeks 4 weeks 8 weeks 8 weeks Cyclosporine, corticosteroids¹ (parenteral, intra-articular), azathioprine, sulfasalazine, hydroxychloroquine 4 weeks Leflunomide² 8 weeks unless subject undergoes standard cholestyramine or activated charcoal washout in which case 4 weeks washout is required. Cytotoxic agents including chlorambucil, cyclophosphamide, nitrogen mustard, or other alkylating agents 3 months Live vaccinations 1 month Investigational medications 30 days or 5 half lives of the investigational agent whichever is longer Bacille Calmette-Guerin (BCG) vaccination 1 month 1 Subjects will be allowed to take stable doses of oral corticosteroids as specified in inclusion criterion #10; i.e., subjects must be on a stable dose of =10 mg prednisone per day (or equivalent) for at least 2 weeks prior to first administration of study medications. 2 Subjects may be allowed to use leflunomide instead of methotrexate on or after Week 24 of study treatment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method