N/A
Completed N=72
An Observational Quality of Life Study in Participants With Rheumatoid Arthritis Treated With Rituximab
Source: ClinicalTrials.gov NCT02507752 ↗Enrolled (actual)
72
Serious AEs
2.8%
Results posted
Dec 2015
Primary outcomePrimary: Percentage of Participants Achieving an Improvement of at Least 0.22 Units in Health Assessment Questionnaire (HAQ) at Week 24 — 57.9 Percentage
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving an Improvement of at Least 0.22 Units in Health Assessment Questionnaire (HAQ) at Week 24 |
57.9 | — |
| PRIMARY Mean Change From Baseline in the Short-Form (SF-36) Health Survey Physical Component Score and Mental Component Score at Week 24 |
14.6; 9.8 | < 0.001 sig |
| SECONDARY Number of Participants With Infusion Reactions, Infectious Events and / or Other Adverse Events in the 24 Weeks After the Start of Treatment. |
15; 5; 21 | — |
| SECONDARY Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) |
-7.5; -11.5 | = 0.021 sig |
| SECONDARY Mean Change From Baseline in C-reactive Protein (CRP). |
-0.3; -0.5 | = 0.744 |
| SECONDARY Mean Change From Baseline in Swollen Joint Count (SJC) |
-5.2; -5.1 | < 0.001 sig |
| SECONDARY Mean Change From Baseline in Tender Joint Count (TJC) |
-6; -7 | < 0.001 sig |
| SECONDARY Mean Change From Baseline in Disease Activity Score 28 Joints (DAS28) Score |
-1.5; -1.7 | < 0.001 sig |
| SECONDARY Mean Change From Baseline in Patient Global Assessment (100 mm VAS) |
-25.6; -23.6 | < 0.001 sig |
| SECONDARY Change in HAQ Score From Screening to Weeks 12 and 24 |
-0.22; -0.31 | = 0.011 sig |
| SECONDARY Change in Pain Scale (100-mm VAS) From Screening to Weeks 12 and 24 |
-17.9; -20.7 | < 0.001 sig |
| SECONDARY Change in SF-36 Physical and Mental Component Scores From Screening to Week 12 |
11.2; 10.9 | = 0.001 sig |
| SECONDARY Change in SF-36 Domain Scores From Screening to Week (Wk) 12 and 24 |
7.2; 7.6; 15.4; 21.6; 14.2; 17.6 | = 0.102 |
| SECONDARY Percentage of Participants Achieving a Clinically Important Reduction of >= 0.22 Point in HAQ Score at Week 12. |
47.5 | — |
| 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. |
74.4; 69.4; 74.4; 65.8 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02507752). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.