Phase 4
Completed N=84
Effect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT03449758 ↗Enrolled (actual)
84
Serious AEs
11.9%
Results posted
Aug 2020
Primary outcomePrimary: Change From Baseline in Rheumatoid Arthritis Impact of Disease Total Score at Week 24 — -2.4 score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Primary Objective:
To assess the effect of sarilumab in combination with conventional synthetic Disease-Modifying Anti-Rheumatic Drug (csDMARD) and/or monotherapy on participant-reported impact of disease, using the rheumatoid arthritis impact of disease (RAID) questionnaire, in participants with moderately to severely active rheumatoid arthritis (RA) and inadequate response or intolerance to current csDMARD or tumor necrosis factor (TNF) inhibitors.
Secondary Objectives:
* To assess the change of the RAID score from baseline (to Week 4, Week 12, and Week 24) in participants with moderately to severely active RA and inadequate response or intolerance to current csDMARD or TNF inhibitors, treated with sarilumab in combination with csDMARD and/or monotherapy.
* To assess the effect of sarilumab in combination with csDMARD and/or monotherapy on other participant-reported outcomes (global assessment of disease activity, disability, morning stiffness, fatigue, anxiety/depression, mood disorders, and physical activities) in participants with moderately to severely active RA and inadequate response or intolerance to current csDMARD or TNF inhibitors.
* To assess the efficacy of sarilumab in combination with csDMARD and/or monotherapy using disease activity score-28 for RA with erythrocyte sedimentation rate (DAS28-ESR) and clinical disease activity index in participants with moderately to severely active RA and inadequate response or intolerance to current csDMARD or TNF inhibitors.
* To assess the safety of sarilumab in combination with csDMARD and/or monotherapy in participants with moderately to severely active RA and inadequate response or intolerance to current csDMARD or TNF inhibitors.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Rheumatoid Arthritis Impact of Disease Total Score at Week 24 |
-2.4 | — |
| SECONDARY Rheumatoid Arthritis Impact of Disease Total Score at Baseline, Weeks 4, 12 and 24 |
4.6; 3.9; 3.3 | — |
| SECONDARY Change From Baseline in Rheumatoid Arthritis Impact of Disease Total Score at Weeks 4 and 12 |
-1.2; -1.8 | — |
| SECONDARY Hospital Anxiety and Depression Scale (HADS): Anxiety (HADS-A) and Depression (HADS-D) Subscale Scores at Baseline, Weeks 4, 12, and 24 |
8.1; 7.2; 6.1; 6.6; 7.0; 6.6 | — |
| SECONDARY Change From Baseline in Hospital Anxiety and Depression Scale: Anxiety (HADS-A) and Depression (HADS-D) Subscale Scores at Weeks 4, 12 and 24 |
-1.0; -2.1; -1.9; -0.4; -1.2; -1.7 | — |
| SECONDARY Multidimensional Assessment of Thymic States (MAThyS) Scale Total Score at Baseline, Weeks 4, 12 and 24 |
88.4; 89.6; 94.8; 90.9 | — |
| SECONDARY Change From Baseline in Multidimensional Assessment of Thymic States Scale Total Score at Weeks 4, 12 and 24 |
-0.2; 2.9; -1.1 | — |
| SECONDARY Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Total Scores at Baseline, Weeks 4, 12 and 24 |
25.5; 21.0; 18.8; 17.9 | — |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Total Scores at Weeks 4, 12 and 24 |
-4.8; -6.4; -7.6 | — |
| SECONDARY Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) Total Score at Baseline, Weeks 4, 12 and 24 |
1.3; 1.1; 0.8; 0.8 | — |
| SECONDARY Change From Baseline in Stanford Health Assessment Questionnaire Disability Index Total Score at Weeks 4, 12 and 24 |
-0.2; -0.4; -0.5 | — |
| SECONDARY Duration of Morning Stiffness at Baseline, Weeks 4, 12, and 24 |
72.3; 34.7; 28.9; 21.3 | — |
| SECONDARY Change From Baseline in Duration of Morning Stiffness at Weeks 4, 12, and 24 |
-39.9; -47.9; -52.8 | — |
| SECONDARY International Physical Activity Questionnaire (IPAQ) Total Score at Baseline, Weeks 4, 12 and 24 |
1759.9; 1881.1; 2061.0; 2089.5 | — |
| SECONDARY Change From Baseline in International Physical Activity Questionnaire Total Score at Weeks 4, 12 and 24 |
175.6; 533.4; 382.0 | — |
| SECONDARY Patient Global Assessment (PtGA) of Disease Activity Score by Visual Analog Scale (VAS) at Baseline, Weeks 4, 12 and 24 |
61.1; 44.1; 36.6; 34.6 | — |
| SECONDARY Change From Baseline in Patient Global Assessment of Disease Activity Score by Visual Analog Scale at Weeks 4, 12, and 24 |
-17.2; -24.3; -26.7 | — |
| SECONDARY Erythrocyte Sedimentation Rate (ESR) at Baseline, Weeks 4, 12, and 24 |
28.8; 10.5; 9.2; 8.4 | — |
| SECONDARY Change From Baseline in Erythrocyte Sedimentation Rate at Weeks 4, 12, and 24 |
-18.1; -19.5; -22.0 | — |
| SECONDARY Disease Activity Score-28 for Rheumatoid Arthritis With Erythrocyte Sedimentation Rate (DAS28-ESR) at Baseline, Weeks 4, 12, and 24 |
5.0; 3.1; 2.6; 2.3 | — |
| SECONDARY Change From Baseline in Disease Activity Score-28 for Rheumatoid Arthritis With Erythrocyte Sedimentation Rate at Weeks 4, 12, and 24 |
-1.8; -2.3; -2.7 | — |
| SECONDARY Clinical Disease Activity Index (CDAI) Total Score at Baseline, Weeks 4, 12, and 24 |
22.5; 12.6; 9.9; 8.1 | — |
| SECONDARY Change From Baseline in Clinical Disease Activity Index Total Score at Weeks 4, 12, and 24 |
-9.8; -12.2; -14.6 | — |
| SECONDARY Number of Swollen Joints at Baseline, Weeks 4, 12, and 24 |
6.3; 2.5; 1.9; 1.6 | — |
| SECONDARY Change From Baseline in Number of Swelling Joints at Weeks 4, 12, and 24 |
-3.9; -4.1; -4.7 | — |
| SECONDARY Number of Tender Joints at Baseline, Weeks 4, 12, and 24 |
7.3; 4.7; 3.5; 2.5 | — |
| SECONDARY Change From Baseline in Number of Tender Joints at Weeks 4, 12, and 24 |
-2.5; -3.7; -4.8 | — |
| SECONDARY Number of Participants Achieving Low Disease Activity (DAS28 ESR Score <=3.2) and Remission (DAS28 ESR Score <2.6) at Weeks 12, and 24 |
12; 4; 40; 45 | — |
| SECONDARY Number of Participants Achieving Clinical Disease Activity Index: Low Disease Activity (CDAI Score <=10.0) and Remission (CDAI Score <=2.8) Weeks 12, and 24 |
29; 29; 18; 20 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
10; 76; 0 | — |
Eligibility Criteria
Inclusion criteria
- Participants with moderately to severely active RA to European League against Rheumatology (EULAR)/American College of Rheumatology (ACR) Criteria.
- Participants with moderate to severe disease activity defined as a DAS28-ESR greater than (>) 3.2 at Screening.
- Participants with inadequate response within at least the last 3 months or intolerance to current csDMARD or to at least one anti-TNF therapy (as defined by the investigator).
- Oral corticosteroids (less than or equal to [ 1.5 x upper limit of normal (ULN).
- Bilirubin (total) >ULN, unless Gilbert's disease has been determined by genetic testing and has been documented
- Total fasting cholesterol >3.50 gram per liter (g/L) [9.1 millimoles per liter {mmol/L}]) or triglycerides >5.00 g/L [5.6 mmol/L]).
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT03449758). 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.