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

Rheumatoid Arthritis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00424502
• Other study ID #: ML20538
• Status: Completed
• Phase: Phase 4
• First received: January 18, 2007
• Last updated: June 12, 2014
• Start date: January 2007
• Est. completion date: October 2009

Study information

• Verified date: June 2014
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• rituximab [MabThera/Rituxan]
1g iv on days 1 and 15
• Methotrexate
10-25mg po/week

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Activity Score Based on 28-Joint Count (DAS28)	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.	Day 0 and Week 24	No
Secondary	Health Assessment Questionnaire - Disability Index (HAQ-DI) Scores	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).	Day 0 and Week 24	No
Secondary	Anti-cyclic Citrullinated Peptide (Anti-CCP)	Anti-CCP measured as absorbance units per milliliter (AU/mL).	Day 0 and Week 24	No
Secondary	Vascular Endothelial Growth Factor (VEGF)	VEGF was measured as picograms per milliliter (pg/mL).	Day 0 and Week 24	No
Secondary	Erythrocyte Sedimentation Rate (ESR)	ESR was measured in mm/hr.	Day 0 and Week 24	No
Secondary	C-Reactive Protein (CRP)	CRP was measured in milligrams per liter (mg/L).	Day 0 and Week 24	No