Health Condition 1: null- Rheumatoid Arthritis (RA), according to ACR criteria (1987), of at least 6 months duration
Conditions
Interventions
Intervention1: DRL_RI: DRL_RI
1000 mg IV infusion on Day 1 & Day 15
Control Intervention1: US-licensed Rituxan®: US-licensed Rituxan®
Rituximab 1000 mg IV infusion on Day 1 & Day 15
Control Inte
Sponsors
Dr Reddys Laboratories Ltd
Quintiles
Eligibility
Inclusion criteria
Inclusion criteria: Key inclusion criteria: Both genders, 18-65 years (inclusive) ï?§ Diagnosis of RA, according to ACR criteria (1987), of at least 6 months duration ï?§ At randomization, tender joint count >=6 and swollen joint count >=6 (from the 66/68 joint count system) ï?§ Evidence of at least moderate disease activity defined as all of the below: â?? Serum CRP level >=1 x ULN or ESR >=28 mm â?? Positive RF and/or CCP â?? DAS28-CRP >3.2 despite stabilized therapy for at least last 4 weeks Patients receiving oral or parenteral MTX 15 to 25 mg per week when given alone or 10 to 25 mg per week in combination with additional non-biologic DMARD(s) (hydroxychloroquine, sulfasalazine) for at least 6 months and on stable dose for at least 3 months , with active disease requiring additional therapy per criteria 3 and 4 No changes expected in MTX (last 3 months) or other DMARD dose or route of administration in the 4 weeks prior to randomization: MTX [15 to 25 mg/week] OR MTX [10 to 25 mg/week] + hydroxychloroquine [200 to 400 mg/day] OR MTX [10 to 25 mg/week] + sulfasalazine [2 to 3 g/day]) Chest X-ray not suggestive of any lung infections including pulmonary TB
Exclusion criteria
Exclusion criteria: Key exclusion criteria: ï?§ Prior therapy with any of the following: â?? Alkylating agents or azathioprine â?? Rituximab, abatacept, tocilizumab, anakinra or an agent/antibody targeting CD20, CD19 or B cells â?? TNF-alfa antagonists or other biologic DMARDs â?? Leflunomide therapy within 3 months of screening ï?§ Patients currently receiving double/triple DMARDs with azathioprine or leflunomide or any agent requiring more than 4 weeks washout ï?§ Patients taking high potency opioid analgesics (e.g., methadone, hydromorphone, morphine) ï?§ Patients who have had any therapy with intra-articular injections (e. g., corticoids) required for a flare up and up to 4 weeks prior to screening ï?§ Patients with systemic manifestations of RA ï?§ Active TB should be ruled out by history and physical examination or chest X ray or any other diagnostic method as deemed necessary by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics, Pharmacodynamics, Safety, Immunogenicity, EfficacyTimepoint: PK: Cmax after 2nd dose-Day 15, AUC0-â?? - Day 1 through Week 16, AUC0-t(2nd dose)- Day 15; PD: Mean change in DAS28-CRP - Weeks 4, 8, 12, and 16, peripheral B-cell counts - Day 1, Day 2, at Weeks 16 & 24; Efficacy: ACR20, ACR50, ACR70 response-Week 24, DAS28-CRP - Week 24, Change in HAQ DI - Week 24; Safety: Incidence of AEs, Infusion reactions, Neutrophil counts, B-cell recovery - 24 and 52 weeks; Immunogenicity: Anti-drug antibodies in all three treatment arms - Weeks 4, 16, 24, and 52 (EOS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic: â?¢ Cmax and area under concentration-time curve from 0 to 336 hours (AUC0-14 days) after first dose â?¢ Time to Cmax (tmax) after each dose and, volume of distribution (Vz), systemic clearance (CL), terminal half-live (t1/2), and terminal elimination rate constant (Kel) after second doseTimepoint: Pharmacokinetic: â?¢ Cmax and area under concentration-time curve from 0 to 336 hours (AUC0-14 days) after first dose o Time Point: 14 days after first dose â?¢ Time to Cmax (tmax) after each dose and, volume of distribution (Vz), systemic clearance (CL), terminal half-live (t1/2), and terminal elimination rate constant (Kel) after second dose o Time Point: Time to Cmax (tmax): After Day 1 and Day 15 Other: after Day 15 | — |
Countries
India, Ukraine
Contacts
Public ContactDevas Seth
Dr. Reddyâ??s Laboratories Ltd.
Outcome results
None listed