An Observational Quality of Life Study in Participants With Rheumatoid Arthritis Treated With Rituximab

NCT02507752 | Completed Results

• 1 other identifier: ML22064
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 20

Brief Summary

This multicenter prospective observational study will evaluate the quality of life in participants with rheumatoid arthritis (RA) who are initiated with rituximab (MabThera/Rituxan). Participants will be followed for 6 months from initiation of treatment.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Achieving an Improvement of at Least 0.22 Units in Health Assessment Questionnaire (HAQ) at Week 24

  The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. The proportion of participants achieving a clinically important reduction of \>= 0.22 point in HAQ (disease-specific questionnaire) at Week 24 was evaluated. HAQ was assessed using the set of observed cases (OC) at each assessment time. An improvement of 0.22 units in HAQ-DI was considered to be a clinically significant improvement.

  Week 24

• Mean Change From Baseline in the Short-Form (SF-36) Health Survey Physical Component Score and Mental Component Score at Week 24

  SF- 36 investigates the standard of quality of life through a general health assessment and not specific to a particular disease, age or treatment group. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores were computed based on weighted combinations of the 8 domain scores: the Physical Component Summary and the Mental Component Summary. SF-36 was assessed using the set of observed cases (OC) at each assessment time.

  Baseline and Week 24

Secondary Outcomes (13)

• Number of Participants With Infusion Reactions, Infectious Events and / or Other Adverse Events in the 24 Weeks After the Start of Treatment.

  Up to 24 Weeks

• Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR)

  Baseline, Week 12, Week 24

• Mean Change From Baseline in C-reactive Protein (CRP).

  Baseline, Week 12, Week 24

• Mean Change From Baseline in Swollen Joint Count (SJC)

  Baseline, Week 12, Week 24

• Mean Change From Baseline in Tender Joint Count (TJC)

  Baseline, Week 12, Week 24

Study Arms (1)

Rituximab

Participants who are receiving 1000 milligrams (mg) intravenous (IV) infusion of rituximab on Day 1 and Day 15 as part of standard of care of the treating site will be included in this observational study.

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 with RA initiating rituximab

You may qualify if:

• Adult participants of both genders who are 18 years or older
• Diagnosis of RA for at least 6 months according to the criteria of the American College of Rheumatology (ACR) of 1987 for the RA classification
• Participants with medically prescribed or being administered with unique rituximab infusion in the least 3 days, according to the approved label
• Ability to meet the program's requirements and to voluntarily sign the Informed Consent Term.

You may not qualify if:

• Participants who have received any investigational medication within less than or equal to (\<=) 1 year before the first dose of the currently indicated treatment
• Participants with an active infection
• Participants with conditions that may interfere in the ability to understand the requests of data collection and to obey to the study's requirements
• Functional Class IV defined based on the ACR functionality criteria for RA
• Participants who can not or who do not want, for any reason, to answer the questionnaires.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (20)

Unknown Facility

Salvador, Estado de Bahia, 40050-410, Brazil

Location

Unknown Facility

Salvador, Estado de Bahia, 41810-570, Brazil

Location

Unknown Facility

Cuiaba, Mato Grosso do Sul, 78020-450, Brazil

Location

Unknown Facility

Juiz de Fora, Minas Gerais, 36036-330, Brazil

Location

Unknown Facility

Uberlândia, Minas Gerais, 38405-320, Brazil

Location

Unknown Facility

Curtiba, Paraná, 80030-110, Brazil

Location

Unknown Facility

Recife, Pernambuco, 50000-000, Brazil

Location

Unknown Facility

Recife, Pernambuco, 50100-130, Brazil

Location

Unknown Facility

Rio de Janeiro, Rio de Janeiro, 22640102, Brazil

Location

Unknown Facility

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Unknown Facility

Campinas, São Paulo, 13015-001, Brazil

Location

Unknown Facility

Campinas, São Paulo, 13073-350, Brazil

Location

Unknown Facility

Osasco, São Paulo, 06010-080, Brazil

Location

Unknown Facility

Santo André, São Paulo, 09060-650, Brazil

Location

Unknown Facility

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Unknown Facility

São Paulo, São Paulo, 03533-000, Brazil

Location

Unknown Facility

São Paulo, São Paulo, 04026-000, Brazil

Location

Unknown Facility

São Paulo, São Paulo, 04041-000, Brazil

Location

Unknown Facility

São Paulo, São Paulo, 05403-010, Brazil

Location

Unknown Facility

São Paulo, São Paulo, 1228200, Brazil

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

+41 61 6878333

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: July 23, 2015
• First Posted: July 24, 2015
• Study Start: July 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 2, 2016
• Results First Posted: December 29, 2015

Record last verified: 2016-01

Locations

BR (20)