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

Phase 1

• Conditions: Refractory rheumatoid arthritis; MedDRA version: 19.0Level: 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-DE
• Lead Sponsor: Hexal AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-30
• Last Update Posted: 24 October 2016

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

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