A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy and safety in adult patients with active rheumatoid arthritis receiving non-biologic background disease-modifying antirheumatic drugs

INTERVENTION: Product Name: Ofatumumab Product Code: HuMax‐CD20 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Ofatumumab CAS Number: 679 818‐59‐8 Current Sponsor code: HuMax‐CD20 Concentration unit: mg/ml milligram(s)/millilitre Concentration number: 20‐ Route of administration of the placebo: Intravenous use CONDITION: Rheumatoid Arthritis ; MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis PRIMARY OUTCOME: Main Objective: To demonstrate the efficacy of ofatumumab in reducing clinical signs and symptoms in adult RA patients after a single course of ofatumumab Primary end point(s): ACR20 at 24 weeks Secondary Objective: 1) To evaluate the safety after single and repeated courses of ofatumumab; 2) To evaluate long‐term efficacy of repeated courses of ofatumumab; 3) To evaluate the effect on established and novel biomarkers of clinical response after single and repeated courses of ofatumumab; 4) To evaluate the impact on patient reported outcomes after single and repeated courses of ofatumumab; 5) To evaluate the risk of host immune response against ofatumumab after single and repeated courses of ofatumumab INCLUSION CRITERIA: 1) Age = 18 years 2) A diagnosis of rheumatoid arthritis according to the American College of Rheumatology (ACR1987 classification) of at least six months’ duration from diagnosis at screening 3) Active disease at the time of screening as defined by: ‐ = 6 swollen joints (of 66 joints assessed) and ‐ = 6 tender joints (of 68 joints assessed) and 20 mm on the patient’s global VAS disease score and DAS28=3.2 (based on ESR) Note: The swollen and tender joint counts will be re‐assessed at baseline (Visit 2) to ensure these eligibility criteria are fulfilled prior to randomization. Where possible joint count reassessment must be performed at the baseline visit (Visit 2); if this is not feasible it can be done =3 days prior to visit 2. 4) RA functional class I, II or III 5) Treatment with 1 non‐biologic DMARD for at least 12 weeks and at a stable dose for at least 4 weeks prior to Visit 2 (please refer to table 9 for permitted DM