An Observational Study on the Safety and Effectiveness of Rituximab in Patients With Severe Active Rheumatoid Arthritis

NCT01071798 | Completed Results

• 1 other identifier: ML22639
• Study Type: observational
• Target: 1,653
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational study aims to evaluate safety, application and onset of effect of rituximab in clinical routine treatment of severe active rheumatoid arthritis during the first 6 months (in case of re-therapy: 12 months).

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• DAS28 Score

  The DAS28 consists of swollen joint count (SJC) and tender joint count (TJC) measurements, the erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and the Patient's Global Assessment of Disease Activity (participant-rated rheumatoid arthritis \[RA\] activity assessment) with transformed scores ranging 0 to 10; higher scores indicate greater affectation due to disease activity.

  at baseline of each cycle and approximately 15 days, 6 weeks (only cycle 1), 12 weeks (3 months), 18 weeks (only cycle 1), and 24 weeks (6 months) after the start of the respective cycle

• HAQ Disability Index (HAQ-DI)

  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 is 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).

  at baseline of each cycle and approximately 15 days, 6 weeks (only cycle 1), 12 weeks (3 months), 18 weeks (only cycle 1), and 24 weeks (6 months) after the start of the respective cycle

Secondary Outcomes (3)

• Percentage of Participants With a Treatment-Emergent Adverse Event (TEAE)

  during Cycle 1, during Cycle 2, during the trial (within 12 months)

• Number of Participants Who Received Only One Treatment Cycle With Clinically Relevant Changes in HAQ-Score at Last Visit During Therapy Compared to Baseline (Categorized)

  24 weeks after starting Cycle 1

• Number of Participants Who Received Two Cycles With Clinically Relevant Changes in HAQ-Score at Last Visit During Therapy Compared to Baseline (Categorized)

  24 weeks after starting Cycle 2

Study Arms (1)

Main Analysis Set

Participants who received at least one cycle of rituximab

Drug: Rituximab

Interventions

Rituximab DRUG

As prescribed by physician

Also known as: Mabthera, Rituxan

Main Analysis Set

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants starting treatment with rituximab

You may qualify if:

• No pretreatment with rituximab
• Age 18 years or older
• Patients with active, severe rheumatoid arthritis with prescription of rituximab according to German Summary of Product Characteristics (SmPC - "Fachinformation")
• Patients with signed informed consent
• Female patients with secure contraception

You may not qualify if:

• Violation of Selection criteria:
• Active severe infection
• Severe heart failure (NYHA class IV) or severe, uncontrollable heart disease
• Participation in an interventional study within the last 3 months before therapy start with rituximab
• Pretreatment with rituximab
• Age \<18 years
• Known intolerability of monoclonal antibodies or chimeric monoclonal antibodies
• Known pregnancy or breastfeeding
• Data of patients without approval of data by the physician
• Patients without informed consent
• Double documentation

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Berlin, 13125, Germany

Location

Related Publications (1)

• Tony HP, Roll P, Mei HE, Blumner E, Straka A, Gnuegge L, Dorner T; FIRST/ ReFIRST study teams. Combination of B cell biomarkers as independent predictors of response in patients with rheumatoid arthritis treated with rituximab. Clin Exp Rheumatol. 2015 Nov-Dec;33(6):887-94. Epub 2015 Oct 30.

  PMID: 26517829 RESULT

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Rituximab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

1-800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2010
• First Posted: February 19, 2010
• Study Start: January 1, 2010
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: February 22, 2016
• Results First Posted: February 22, 2016

Record last verified: 2016-01

Locations

DE (1)