Clinical trial NCT02507752: An Observational Quality of Life Study in Participants With Rheumatoid Arthritis Treated With Rituximab
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-07-24
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with RA initiating rituximab

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Achieving an Improvement of at Least 0.22 Units in Health Assessment Questionnaire (HAQ) at Week 24
timeFrame: Week 24
measure: Mean Change From Baseline in the Short-Form (SF-36) Health Survey Physical Component Score and Mental Component Score at Week 24
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Number of Participants With Infusion Reactions, Infectious Events and / or Other Adverse Events in the 24 Weeks After the Start of Treatment.
timeFrame: Up to 24 Weeks
measure: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
timeFrame: Baseline, Week 12, Week 24
measure: Mean Change From Baseline in C-reactive Protein (CRP).
timeFrame: Baseline, Week 12, Week 24
measure: Mean Change From Baseline in Swollen Joint Count (SJC)
timeFrame: Baseline, Week 12, Week 24
measure: Mean Change From Baseline in Tender Joint Count (TJC)
timeFrame: Baseline, Week 12, Week 24
measure: Mean Change From Baseline in Disease Activity Score 28 Joints (DAS28) Score
timeFrame: Baseline, Week 12, Week 24
measure: Mean Change From Baseline in Patient Global Assessment (100 mm VAS)
timeFrame: Baseline, Week 12, Week 24
measure: Change in HAQ Score From Screening to Weeks 12 and 24
timeFrame: Baseline, Week 12, Week 24
measure: Change in Pain Scale (100-mm VAS) From Screening to Weeks 12 and 24
timeFrame: Baseline, Week 12, Week 24
measure: Change in SF-36 Physical and Mental Component Scores From Screening to Week 12
timeFrame: Baseline, Week 12
measure: Change in SF-36 Domain Scores From Screening to Week (Wk) 12 and 24
timeFrame: Baseline, Week 12, Week 24
measure: Percentage of Participants Achieving a Clinically Important Reduction of >= 0.22 Point in HAQ Score at Week 12.
timeFrame: Week 12
measure: 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.
timeFrame: Week 12 and 24
Other outcomes:
Locations:
city: Salvador
country: Brazil
state: BA
city: Salvador
country: Brazil
state: BA
city: Juiz de Fora
country: Brazil
state: MG
city: Uberlandia
country: Brazil
state: MG
city: Cuiaba
country: Brazil
state: MS
city: Recife
country: Brazil
state: PE
city: Recife
country: Brazil
state: PE
city: Curtiba
country: Brazil
state: PR
city: Rio De Janeiro
country: Brazil
state: RJ
city: Porto Alegre
country: Brazil
state: RS
city: Campinas
country: Brazil
state: SP
city: Campinas
country: Brazil
state: SP
city: Osasco
country: Brazil
state: SP
city: Santo Andre
country: Brazil
state: SP
city: Sao Jose do Rio Preto
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: