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OpenTrials
Completed

NCT Number: NCT00424502

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Budapest, Hungary

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rituximab [MabThera/Rituxan]

Drug

1g iv on days 1 and 15

Other names: MabThera/Rituxan

methotrexate

Drug

10-25mg po/week

Primary outcomes

  1. Disease Activity Score Based on 28-Joint Count (DAS28)

    Time frame: Day 0 and Week 24

    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 outcomes

  1. Health Assessment Questionnaire - Disability Index (HAQ-DI) Scores

    Time frame: Day 0 and Week 24

    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).

  2. Anti-cyclic Citrullinated Peptide (Anti-CCP)

    Time frame: Day 0 and Week 24

    Anti-CCP measured as absorbance units per milliliter (AU/mL).

  3. Vascular Endothelial Growth Factor (VEGF)

    Time frame: Day 0 and Week 24

    VEGF was measured as picograms per milliliter (pg/mL).

  4. Erythrocyte Sedimentation Rate (ESR)

    Time frame: Day 0 and Week 24

    ESR was measured in mm/hr.

  5. C-Reactive Protein (CRP)

    Time frame: Day 0 and Week 24

    CRP was measured in milligrams per liter (mg/L).

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jan 19, 2007
Registry last updated
May 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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