A clinical trial to study the effects of Three Anti-CD20 Monoclonal Antibodies in Patients with Moderate to Severe Active, Seropositive Rheumatoid Arthritis with an Inadequate Response to Methotrexate Based Therapy.

Phase 1

Completed

• Conditions: Health Condition 1: null- Rheumatoid Arthritis (RA), according to ACR criteria (1987), of at least 6 months duration

• Registration Number: CTRI/2014/09/004954
• Lead Sponsor: Dr Reddys Laboratories Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified