A study to Evaluate effects of GP2013 drug, Safety and Efficacy of GP2013 and Rituximab in Patients With Rheumatoid Arthritis

A Randomized, Double-blind, Controlled Study to Evaluate Pharmokinetic, Pharmacodynamic, Safety and Efficacy of GP2013 and Rituximab in Patients With Rheumatoid Arthritis Refractory or Intolerant to Standard DMARDs and One or Two Anti-TNF Therapies.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/06/001781

Enrollment

312

Registered

2011-06-03

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Rheumatoid Arthritis

Interventions

Intervention1: GP2013: 1000 mg I.V. on two separate occasions, 2 weeks apart Control Intervention1: Rituximab: 1000 mg I.V. on two separate occasions, 2 weeks apart

Eligibility

Inclusion criteria

Inclusion criteria: 1. Rheumatoid arthritis as defined by the 1987 ACR classification 2. Severe active seropositive disease 3. Inadequate response or intolerance to other DMARDs and anti-TNFs 4. Treatment with Methotrexate

Exclusion criteria

Exclusion criteria: 1.Patients with systemic manifestations of rheumatoid arthritis 2.Female patients nursing 3.Women of childbearing potential unless using birth control 4. Active infection 5. Known immunodeficiency syndrome 6.Positive Hepatitis B surface antigen or antibodies to Hepatitis C 7.History of cancer 8.Other protocol-defined inclusion/exclusion criteria may apply

Design outcomes

Secondary

Measure	Time frame
Additional pharmacokinetic (PK) parameters, pharmacodynamic (PD) and efficacy of GP2013 and rituximab in subjects with RATimepoint: 1.5 years;Safety and tolerability of GP2013 and rituximab in patients with RATimepoint: 1.5 years	—

Primary

Measure	Time frame
Compare pharmacokinetics (PK) of GP2013 and rituximab following IV infusion in patients with RATimepoint: 24 weeks	—

Countries

Argentina, Austria, Brazil, France, Germany, India, Italy, Spain, Turkey

Contacts

Public ContactMurugananthan K

Novartis Healthcare Pvt Ltd

murugananthan.k@novartis.com02224958545

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026