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

Rheumatoid Arthritis Clinical Trial

Official title:

An Observational, Prospective, Multicenter, Local, to Assess the Quality of Life Through the Use of Questionnaires in a Cohort of Patients With Rheumatoid Arthritis Treated With Anti-CD20 Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02507752
• Other study ID #: ML22064
• Status: Completed
• Phase: N/A
• First received: July 23, 2015
• Last updated: January 3, 2016
• Start date: July 2009
• Est. completion date: June 2012

Study information

• Verified date: January 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Country: Brazil
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Number of Participants With Infusion Reactions, Infectious Events and / or Other Adverse Events in the 24 Weeks After the Start of Treatment.	An infusion reaction is defined as an adverse event that occurs during infusion or within 24 hours after infusion of Rituximab. All infectious events, whether considered related or not to Rituximab, were collected for the safety analysis of the study. An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.	Up to 24 Weeks	No
Secondary	Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR)	Erythrocyte Sedimentation Rate is an acute phase reactant and a measure of inflammation.	Baseline, Week 12, Week 24	No
Secondary	Mean Change From Baseline in C-reactive Protein (CRP).	CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as Rheumatoid Arthritis.	Baseline, Week 12, Week 24	No
Secondary	Mean Change From Baseline in Swollen Joint Count (SJC)	A swollen joint count is the most specific clinical method to quantify abnormalities in participants with rheumatoid arthritis (RA). It reflects the amount of inflamed synovial tissue.	Baseline, Week 12, Week 24	No
Secondary	Mean Change From Baseline in Tender Joint Count (TJC)	A tender joint count is the most specific clinical method to quantify abnormalities in participants with rheumatoid arthritis (RA). It is associated more with the level of pain.	Baseline, Week 12, Week 24	No
Secondary	Mean Change From Baseline in Disease Activity Score 28 Joints (DAS28) Score	DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.	Baseline, Week 12, Week 24	No
Secondary	Mean Change From Baseline in Patient Global Assessment (100 mm VAS)	The Physician's Global Assessment of disease activity was assessed using a 0 to 100 mm horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity).Change from Baseline = scores at observation minus score at Baseline. An increase in score from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.	Baseline, Week 12, Week 24	No
Secondary	Change in HAQ Score From Screening to Weeks 12 and 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 number 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.	Baseline, Week 12, Week 24	No
Secondary	Change in Pain Scale (100-mm VAS) From Screening to Weeks 12 and 24	Visual Analogue Scale (VAS) is a 100 millimeter (mm) scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain. Change from Screening=scores at observation minus score at Screening. An increase in score from Screening represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. The change in pain scale was analyzed for the set of observed cases (OC) at each assessment time.	Baseline, Week 12, Week 24	No
Secondary	Change in SF-36 Physical and Mental Component Scores From Screening to Week 12	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, Week 12	No
Secondary	Change in SF-36 Domain Scores From Screening to Week (Wk) 12 and 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, Week 12, Week 24	No
Secondary	Percentage of Participants Achieving a Clinically Important Reduction of >= 0.22 Point in HAQ Score at Week 12.	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 12	No
Secondary	Percentage of Participants Achieving a Clinically Important Increase of >=5 Points in the SF-36 Physical and Mental Component Scores at Weeks 12 and 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.	Week 12 and 24	No