A Phase IIB, Monotherapy in Patients with Rheumatoid Arthritis

• Research type

  Research Study

• Full title

  A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis

• IRAS ID

  63939

• Contact name

  Peter Taylor

• Sponsor organisation

  Astrazeneca AB

• Eudract number

  2010-023692-26

• Clinicaltrials.gov Identifier

  NCT01264770

• Research summary

  The study is a 24-week, multi-centre, randomised, double-blind (administrator unblinded), placebo-controlled (for 6 weeks), parallel group study to investigate the efficacy and safety of FosD monotherapy in patients with active RA. Eligible patients will include those who are not currently receiving disease-modifying anti rheumatic drug (DMARDs; DMARD naÇîve, intolerant to DMARDs or have had an inadequate response to DMARDs). There is no minimum or maximum number of patients in each subgroup but randomisation will be stratified by DMARD naive versus DMARD inadequate response (IR)/intolerant. Patients must not have used DMARDs within 6 weeks prior to Visit 1 in order to be eligible to participate in the study. Patients will be randomised to receive 1 of 3 oral dosing regimens of FosD, adalimumab by subcutaneous injection or a matching placebo regimen. Oral study treatment will be taken on a once or twice daily basis and adalimumab/placebo will be administered by injection in the clinic once every 2 weeks. A double-dummy blinding technique will be used to ensure neither patient nor investigator will know which treatment the patient is receiving. Since an exact placebo match for adalimumab is not available, each site will be required to appoint an unblinded administrator for the injection, who will be independent of the rest of the on-site study team. It is planned to randomise approximately 280 patients in total. An adequate number of patients will be randomised to ensure that 250 patients (50 patients in each of the 5 dose regimens) will receive their randomised treatment. At randomisation, the patients allocated to placebo will be assigned to switch to FosD at Week 6 (100 mg FosD bid up to Week 24; or 100 mg FosD bid for 4 weeks, followed by FosD 150 mg qd up to Week 24). Patients who successfully complete the scheduled treatment period will be offered the opportunity to receive FosD therapy in a long term follow-up extension study (OSKIRA-X: Protocol D4300C00005).

• REC name

  West of Scotland REC 1

• REC reference

  11/S0703/5

• Date of REC Opinion

  7 Apr 2011

• REC opinion

  Further Information Favourable Opinion