Clinical trial NCT01274182: GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy
Official title: A Randomized, Double-blind, Controlled Study to Evaluate PK, PD, Safety and Efficacy of GP2013 and Rituximab in Patients With Rheumatoid Arthritis Refractory or Intolerant to Standard DMARDs and up to Three Anti-TNF Therapies.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
Collaborators: name: Novartis Pharmaceuticals
First posted: 2011-01-11
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the PK/PD, efficacy and safety of GP2013 in patients with severe rheumatoid arthritis.


Eligibility 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

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

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: AUC(0-inf) of GP2013, MabThera and Rituxan Following IV Infusion in Patients With RA
timeFrame: From baseline to 24 weeks
Secondary outcomes:
measure: Maximum Serum Concentration (Cmax) of GP2013, MabThera and Rituxan Following IV Infusion in Patients With RA
timeFrame: From baseline to week 24
measure: Area Under the Effect Curve From Baseline to Day 14 (AUEC(0-14d)) of Percent B-cells of GP2013, MabThera and Rituxan in Patients With RA
timeFrame: 14 days
measure: Change From Baseline in DAS28(CRP) at Week 24
timeFrame: 24 weeks
measure: Number of Patients With ACR20 (CRP) Response
timeFrame: 24 weeks
measure: Summary of Disease Activity According to CDAI
timeFrame: At week 24
measure: Summary of Disease Activity According to SDAI
timeFrame: At week 24
measure: Participant Response as Assessed by EULAR Response Criteria
timeFrame: At week 24
Other outcomes:
measure: Number of Patients With at Least One Anti-Drug-Antibody (ADA) Positive Serum Sample
timeFrame: through study completion, an average of 1 year
Locations:
city: Los Angeles
country: United States
facility: Miller Clinical Research
state: California
city: Lexington
country: United States
facility: Bluegrass Community Research, Inc.
state: Kentucky
city: Cumberland
country: United States
facility: Klein & Associates
state: Maryland
city: Hagerstown
country: United States
facility: Klein & Associates
state: Maryland
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Lincoln
country: United States
facility: Physician Research Collaboration, LLC
state: Nebraska
city: Las Vegas
country: United States
facility: Innovative Health Research
state: Nevada
city: Charlotte
country: United States
facility: DJL Clinical Research PLLC
state: North Carolina
city: Oklahoma City
country: United States
facility: Health Research of Oklahoma
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Wyomissing
country: United States
facility: Clinical Research Center of Reading LLC
state: Pennsylvania
city: Charleston
country: United States
facility: Low Country Rheumatology, PA
state: South Carolina
city: Rapid City
country: United States
facility: Regional Health Clinical Research
state: South Dakota
city: Jackson
country: United States
facility: West Tennessee Research Institute
state: Tennessee
city: San Antonio
country: United States
facility: Arthritis & Osteoporosis Center of South Texas
state: Texas
city: Seattle
country: United States
facility: The Seattle Arthritis Center
state: Washington
city: Buenos Aires#1
country: Argentina
facility: Investigative Site
city: Buenos Aires#2
country: Argentina
facility: Investigative Site
city: Innsbruck
country: Austria
facility: Investigative Site
city: Vienna#1
country: Austria
facility: Investigative Site
city: Kortrijk
country: Belgium
facility: Investigative site
city: Merksem
country: Belgium
facility: Investigative site
city: Curitiba
country: Brazil
facility: Investigative Site
city: Goiânia
country: Brazil
facility: Investigative Site
city: Sao Paulo#1
country: Brazil
facility: Investigative Site
city: Sao Paulo#2
country: Brazil
facility: Investigative site
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation
city: Amiens Cedex
country: France
facility: Investigative Site
city: Cahors
country: France
facility: Investigative site
city: Corbeil Essonnes
country: France
facility: Investigative Site
city: La Gaillarde
country: France
facility: Investigative site
city: Orleans
country: France
facility: Investigative Site
city: Frankfurt
country: Germany
facility: Investigative Site
city: Freiburg
country: Germany
facility: Investigative Site
city: Göttingen
country: Germany
facility: Investigative Site
city: Hildesheim
country: Germany
facility: Investigative Site
city: Jena
country: Germany
facility: Investigative Site
city: München
country: Germany
facility: Investigative Site
city: Nürnberg
country: Germany
facility: Investigative Site
city: Ratingen
country: Germany
facility: Investigative Site
city: Regensburg
country: Germany
facility: Investigative Site
city: Würzburg
country: Germany
facility: Investigative Site
city: Kistarcsa
country: Hungary
facility: Pest Megyei Flór Ferenc
city: Veszprem
country: Hungary
facility: Megyei Csolnoky Ferenc Kórház Nonprofit Zrt.
city: Ajmer
country: India
facility: Investigative site
city: Bangalore
country: India
facility: Investigative Site
city: Hyderabad
country: India
facility: Investigative Site
city: Jaipur
country: India
facility: Investigative Site
city: New Delhi
country: India
facility: Investigative Site
city: Secunderabad
country: India
facility: Investigative Site
city: Milano
country: Italy
facility: Investigative Site
city: Bucharest#1
country: Romania
facility: Investigative site
city: Bucharest#2
country: Romania
facility: Investigative site
city: Cluj
country: Romania
facility: Investigative site
city: Madrid
country: Spain
facility: Investigative Site
city: Mérida
country: Spain
facility: Investigative Site
city: Santiago de Compostela
country: Spain
facility: Investigative site
city: Sevilla
country: Spain
facility: Investigative Site
city: Istanbul
country: Turkey
facility: Investigative Site
city: Izmir
country: Turkey
facility: Investigative Site
Study officials:
affiliation: Sandoz
name: Sandoz Biopharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Smolen JS, Cohen SB, Tony HP, Scheinberg M, Kivitz A, Balanescu A, Gomez-Reino J, Cen L, Zhu P, Shisha T. A randomised, double-blind trial to demonstrate bioequivalence of GP2013 and reference rituximab combined with methotrexate in patients with active rheumatoid arthritis. Ann Rheum Dis. 2017 Sep;76(9):1598-1602. doi: 10.1136/annrheumdis-2017-211281. Epub 2017 Jun 21.