A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a TNF-Blocker.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00424502
First received: January 18, 2007
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

This single arm study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis whose current treatment with one or more TNF blocker had produced an inadequate response. Patients will receive MabThera (1g infusion) on day 1 and day 15, and will continue on their basic methotrexate therapy (10-25mg/week). The anticipated time on study treatment is 3-12 months, and the target sample size is <100 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/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Study to Evaluate the Effect of MabThera on Treatment Response in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Previous TNF Inhibition.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Disease Activity Score Based on 28-Joint Count (DAS28) [ Time Frame: Day 0 and Week 24 ] [ Designated as safety issue: No ]
    DAS28 consists of swollen joint count (SJC) and tender joint count (TJC) measurements, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]), and Patient Global Assessment of Disease Activity (participant-rated assessment of arthritis) with transformed scores ranging from 0 to 10. Higher scores indicated greater affectation due to disease activity. DAS28 equal to or less than (≤)3.2 equals (=) low disease activity, greater than (>)3.2 to 5.1 = moderate to high disease activity.


Secondary Outcome Measures:
  • Health Assessment Questionnaire - Disability Index (HAQ-DI) Scores [ Time Frame: Day 0 and Week 24 ] [ Designated as safety issue: No ]
    The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. For each of the categories, participants reported the amount of difficulty they had in performing 2 or 3 specific subcategory items. The standard disability score was calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered, yielding a score from 0 (without any difficulty) to 3 (unable to do).

  • Anti-cyclic Citrullinated Peptide (Anti-CCP) [ Time Frame: Day 0 and Week 24 ] [ Designated as safety issue: No ]
    Anti-CCP measured as absorbance units per milliliter (AU/mL).

  • Vascular Endothelial Growth Factor (VEGF) [ Time Frame: Day 0 and Week 24 ] [ Designated as safety issue: No ]
    VEGF was measured as picograms per milliliter (pg/mL).

  • Erythrocyte Sedimentation Rate (ESR) [ Time Frame: Day 0 and Week 24 ] [ Designated as safety issue: No ]
    ESR was measured in mm/hr.

  • C-Reactive Protein (CRP) [ Time Frame: Day 0 and Week 24 ] [ Designated as safety issue: No ]
    CRP was measured in milligrams per liter (mg/L).


Enrollment: 20
Study Start Date: January 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: rituximab [MabThera/Rituxan]
1g iv on days 1 and 15
Other Name: MabThera/Rituxan
Drug: Methotrexate
10-25mg 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;
  • diagnosed RA for >=3 months prior to first administration of study medication;
  • inadequate response or intolerance to >=1 anti-TNF therapies, alone or in combination with methotrexate;
  • if using NSAIDS, analgesics or oral corticosteroids, must be on a stable dose for >=2 weeks prior to start of study.

Exclusion Criteria:

  • other chronic inflammatory diseases;
  • use of parental corticosteroids within 4 weeks prior to screening;
  • severe heart failure, or severe, uncontrolled cardiac disease.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00424502

Locations
Hungary
Budapest, Hungary, 1027
Budapest, Hungary, 1023
Debrecen, Hungary, 4032
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: NCT00424502     History of Changes
Other Study ID Numbers: ML20538
Study First Received: January 18, 2007
Results First Received: June 12, 2014
Last Updated: June 12, 2014
Health Authority: Hungary: Ministry of Health

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

ClinicalTrials.gov processed this record on October 29, 2014