Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Fostamatinib and placebo injections; Fostamatinib and placebo injections; Fostamatinib and placebo injections; Adalimumab and placebo of fostamatinib; Placebo of fostamatinib, fostamatinib, and placebo injections
Intervention description: Fostamatinib 100mg twice daily and placebo injection once every two weeks; Fostamatinib 100mg twice daily / fostamatinib 150mg once daily and placebo injection once every two weeks; Fostamatinib 100mg twice daily / fostamatinib 100mg once daily and placebo injection once every two weeks.; Adalimumab 40mg injection once every two weeks and placebo to fostamatinib twice daily.; Placebo injection once every two weeks. Placebo to fostamatinib for six weeks, followed by fostamatinib 100mg twice daily (Group F) / fostamatinib 100mg twice daily then 150mg once daily (Group G).
Intervention MeSH terms: Adalimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 644.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; OSKIRA; fostamatinib

Summary:

      The purpose of the study is to evaluate the improvements in signs and symptoms of rheumatoid
      arthritis (RA) for fostamatinib compared to placebo or adalimumab in patients who are
      Disease-Modifying anti-rheumatic drug (DMARD) naïve, DMARD intolerant or have had an
      inadequate response to DMARDs. The study will last for approximately six months
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged 18 and over

          -  Active rheumatoid arthritis (RA) diagnosed after the age of 16 and diagnosis within 5
             years prior to study visit 1 and inadequate response to treatment with a maximum 2
             Disease-Modifying anti-rheumatic drug (DMARD) therapies, or diagnosis within 5 years
             prior to study visit 1 and intolerance to DMARD therapy, or diagnosis within 2 years
             prior to study visit 1 and no previous use of DMARDs

          -  4 or more swollen joints and 4 or more tender/painful joints (from 28 joint count) and
             either Erythrocyte Sedimentation Rate (ESR) blood result of 28mm/h or more, or
             C-Reactive Protein (CRP) blood result of 10mg/L or more

          -  At least 2 of the following: documented history or current presence of positive
             rheumatoid factor (blood test), radiographic erosion within 12 months prior to study
             enrolment, presence of serum anti-cyclic citrullinated peptide antibodies (blood test)

        Exclusion Criteria:

          -  Females who are pregnant or breast feeding

          -  Poorly controlled hypertension

          -  Liver disease or significant liver function test abnormalities

          -  Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue
             diseases or chronic pain disorders

          -  Recent or significant cardiovascular disease

          -  Significant active or recent infection including tuberculosis

          -  Previously received treatment with a TNF alpha antagonist (including etanercept,
             certolizumab, adalimumab, infliximab, golimumab) or anakinra or previous treatment
             with other biological agent including rituximab, abatacept and tocilizumab

          -  Use of any DMARDs within 6 weeks before first study visit

          -  Severe renal impairment

          -  Neutropenia