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

• Register: EUCTR
• Last refreshed on: 3 October 2016
• Main ID: EUCTR2010-021184-32-IT
• Date of registration: 02/02/2011
• Prospective Registration: Yes
• Primary sponsor: Hexal AG
• Public title: GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy
• Scientific title: 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
• Date of first enrolment: 03/08/2011
• Target sample size: 164
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-021184-32
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: yes Other specify the comparator: Rituximab Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Drug Regulatory Affairs
• Affiliation: Novartis Farma S.p.A.

• Name: Drug Regulatory Affairs
• Affiliation: Novartis Farma S.p.A.

Key inclusion & exclusion 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 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Refractory rheumatoid arthritis
MedDRA version: 16.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Intervention(s)

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
Concentration number: 1000-

Trade Name: Mabthera
Product Name: MabThera
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-

Trade Name: Rituxan (INN: Rituximab), brand name in the United States
Product Name: Rituxan
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-

Primary Outcome(s)

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

Timepoint(s) of evaluation of this end point: Primary endpoint determined based on serum samples collected over
24 weeks.

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 ]

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.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Please refer to the clinical study protocol for additional details.

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.

Secondary ID(s)

2010-021184-32-DE

GP13-201

Source(s) of Monetary Support

HEXAL AG