GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy

A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolerant to standard DMARDs and one or up to three anti-TNF therapies

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-021184-32-DE

Enrollment

164

Registered

2010-08-30

Start date

2010-11-30

Completion date

Unknown

Last updated

2016-10-24

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

Conditions

Refractory rheumatoid arthritis MedDRA version: 19.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Product Name: NA Product Code: GP2013 Pharmaceutical Form: Concentrate for solution for infusion Current Sponsor code: GP2013 Concentration unit: mg/g milligram(s)/gram Concentration type: equal Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Rheumatoid arthritis as defined by the 1987 ACR classification •Severe active seropositive disease •Inadequate response or intolerance to other DMARDs and anti-TNFs •Treatment with Methotrexate For additional inclusion criteria, please refer to section 4.1 of the protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: •Patients with systemic manifestations of rheumatoid arthritis •Female patients nursing •Women of childbearing potential unless using birth control •Active infection •Known immunodeficiency syndrome •Positive Hepatitis B surface antigen or antibodies to Hepatitis C •History of cancer For additional exclusion criteria, please refer to section 4.2 of the protocol.

Design outcomes

Primary

Measure	Time frame
Main Objective: Compare pharmacokinetics (PK) of GP2013 and rituximab following IV infusion in patients with RA [ Time Frame: 24 weeks ] [ Designated as safety issue: No ];Secondary Objective: • Additional pharmacokinetic (PK) parameters, pharmacodynamic (PD) and efficacy of GP2013 and rituximab in subjects with RA [ Time Frame: 1.5 years ] [ Designated as safety issue: No ] • Safety and tolerability of GP2013 and rituximab in patients with RA [Time Frame: 1.5 years ] [ Designated as safety issue: No ] For additional secondary objectives please see full protocol;Primary end point(s): The primary PK variable is • AUC(0-8), i.e. the PK profile will be derived over the entire 1st treatment course including both infusions, of GP2013 and rituximab concentrations determined in serum samples collected over 24 weeks.;Timepoint(s) of evaluation of this end point: Primary endpoint determined based on serum samples collected over 24 weeks.	—

Measure

Time frame

Main Objective: Compare pharmacokinetics (PK) of GP2013 and rituximab following IV infusion in patients with RA [ Time Frame: 24 weeks ] [ Designated as safety issue: No ];Secondary Objective: • Additional pharmacokinetic (PK) parameters, pharmacodynamic (PD) and efficacy of GP2013 and rituximab in subjects with RA [ Time Frame: 1.5 years ] [ Designated as safety issue: No ] • Safety and tolerability of GP2013 and rituximab in patients with RA [Time Frame: 1.5 years ] [ Designated as safety issue: No ] For additional secondary objectives please see full protocol;Primary end point(s): The primary PK variable is • AUC(0-8), i.e. the PK profile will be derived over the entire 1st treatment course including both infusions, of GP2013 and rituximab concentrations determined in serum samples collected over 24 weeks.;Timepoint(s) of evaluation of this end point: Primary endpoint determined based on serum samples collected over 24 weeks.

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Secondary

Measure	Time frame
Secondary end point(s): PK parameter: Cmax of the 1st infusion PD parameter: depletion of CD20 positive peripheral B cells (cells/µL) Please refer to the clinical study protocol for additional details.;Timepoint(s) of evaluation of this end point: Please refer to the clinical study protocol for additional details.	—

Countries

Argentina, Austria, Belgium, Brazil, Bulgaria, Estonia, France, Germany, Hungary, India, Italy, Poland, Romania, Spain, Turkey, United Kingdom

Contacts

Public ContactDr .med. Jasmin Khan-Boluki, MSc

HEXAL AG

jasmin.khan-boluki@sandoz.com+4980244762914

Outcome results

None listed

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