A Non-Comparative Study to Assess the Safety of MabThera (Rituximab) in Patients With Rheumatoid Arthritis.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00502996
First received: July 17, 2007
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

This single arm study will assess the safety of MabThera plus methotrexate in patients with rheumatoid arthritis who have had a lack of response to 1-5 DMARDs or biological agents. Patients will receive MabThera (1g i.v.) on days 1 and 15, concomitantly with methotrexate >=15mg p.o./week. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: rituximab [MabThera/Rituxan]
Drug: Methotrexate
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Expanded Access Program to Assess the Safety of MabThera in Patients With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Adverse event incidence and profile [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 235
Study Start Date: February 2006
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: rituximab [MabThera/Rituxan]
1g iv on days 1 and 15
Drug: Methotrexate
>=15 mg po/week

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • rheumatoid arthritis >=6 months;
  • lack of response to 1-5 DMARDs or biological agents;
  • rheumatoid factor positive.

Exclusion Criteria:

  • other chronic inflammatory articular disease or systemic rheumatic disease;
  • joint or bone surgery during 8 weeks prior to randomization;
  • previous treatment with any cell-depleting therapy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00502996

  Hide Study Locations
Locations
Argentina
Buenos Aires, Argentina, C1426AAL
Buenos Aires, Argentina, C1280AEB
Buenos Aires, Argentina, 1425
Córdoba, Argentina, 5000
San Miguel de Tucuman, Argentina, 4000
Tucuman, Argentina, 4000
Brazil
Belem, Brazil, 66063-240
Brasilia, Brazil, 70322000
Brasilia, Brazil, 70390-904
Campinas, Brazil, 13025-141
Campinas, Brazil, 13015-001
Curitiba, Brazil, 80730-000
Florianopolis, Brazil, 88040-970
Fortaleza, Brazil, 60430-370
Fortaleza, Brazil, 60155-290
Goiania, Brazil, 74110010
Nova Lima, Brazil, 34000-000
Porto Alegre, Brazil, 90610-000
Recife, Brazil, 50000-000
Ribeirão Preto, Brazil, 14048-900
Rio de Janeiro, Brazil, 22050-000
Rio de Janeiro, Brazil, 22640102
Rio de Janeiro, Brazil, 20551-030
Rio de Janeiro, Brazil, 21941-590
Salvador, Brazil, 40050-410
Sao Paulo, Brazil, 04039-004
Sao Paulo, Brazil, 05403-000
Sao Paulo, Brazil, 04038-002
Sao Paulo, Brazil, 03128-050
Sao Paulo, Brazil, 04038-040
Sao Paulo, Brazil, 04026-000
Vitoria, Brazil, 29043-910
Chile
Santiago, Chile
Colombia
Barranquilla, Colombia
Bogota, Colombia
Ecuador
Cuenca, Ecuador, 1394
Guayaquil, Ecuador
Quito, Ecuador, 1394
El Salvador
San Salvador, El Salvador
Mexico
Mexico City, Mexico, 02990
Mexico City, Mexico, 14080
Mexico City, Mexico, 06920
San Luis Potosi, Mexico, 78240
Peru
Jesus Maria, Peru
Lima, Peru, 13
San Isidro, Peru, LIMA 27
Uruguay
Montevideo, Uruguay, 11600
Venezuela
Barquisimeto, Venezuela, 3005
Caracas, Venezuela, 1010
Caracas, Venezuela, 1040
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00502996     History of Changes
Other Study ID Numbers: ML19385
Study First Received: July 17, 2007
Last Updated: April 7, 2014
Health Authority: Mexico: Ministry of Health

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Rituximab
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014