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

Phase 1

Conditions: Refractory rheumatoid arthritis
MedDRA version: 16.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2010-021184-32-IT

Lead Sponsor: Hexal AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 164

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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 64

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 ]<br><br><br>;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 ]<br><br>• Safety and tolerability of GP2013 and rituximab in patients with RA [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]<br><br><br><br>For additional secondary objectives please see full protocol;Primary end point(s): The primary PK variable is<br>• 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<br>24 weeks.;Timepoint(s) of evaluation of this end point: Primary endpoint determined based on serum samples collected over<br>24 weeks.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): PK parameter: Cmax of the 1st infusion<br><br>PD parameter: depletion of CD20 positive peripheral B cells (cells/µL)<br><br>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.