Effect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03449758
• Date of registration: 08/02/2018
• Prospective Registration: Yes
• Primary sponsor: Sanofi
• Public title: Effect of Sarilumab on Patient-reported Outcomes in Patients With Active Rheumatoid Arthritis SariPRO
• Scientific title: Effect of Sarilumab on Patient-reported Outcomes in Patients With Moderately to Severely Active Rheumatoid Arthritis and With Inadequate Response or Intolerance to Current Conventional Synthetic DMARDs or Tumor Necrosis Factor Inhibitors
• Date of first enrolment: March 5, 2018
• Target sample size: 84
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03449758
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion 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 [<=] 15 mg/day prednisone or equivalent)
and nonsteroidal anti-inflammatory drugs or cyclooxygenase-2 (up to the maximum
recommended dose) were allowed if taken at a stable dose for at least 4 weeks prior to
Baseline.

- Permitted csDMARDs were allowed if taken at a stable dose for at least 4 weeks prior
to Baseline.

- Participants abled and given written informed consent and complied with the
requirements of the study protocol.

Exclusion criteria:

- Less than (<) 18 years of age.

- Participant unable to understand and write adequately to complete the study
participant related outcome assessments.

- Exposure to sarilumab at any time prior to Baseline visit.

- Use of intra-articular or parenteral corticosteroids within 4 weeks prior to Baseline.

- Treatment with any investigational agent within the 4 weeks of Screening.

- Last RA treatment prior to inclusion with any anti-Janus kinase (JAK) or biologic
DMARD other than anti-TNF.

- Participants treated with anti-TNF (i.e. adalimumab, infliximab, certolizumab,
golimumab, etanercept) before the screening period, which are maintained within the 4
weeks before the inclusion (i.e. the first injection of sarilumab).

- Rheumatic autoimmune disease other than RA or prior history or current inflammatory
joint disease other than RA.

- Evidence of active malignant disease, malignancies diagnosed within the previous 10
years (except basal and squamous cell carcinoma of the skin or carcinoma in situ of
the cervix uteri previously excised and cured).

- Participant who was institutionalized due to regulatory or legal order or participant
who was mentally disabled or educationally disadvantaged.

- Pregnant or breastfeeding woman.

- Women of childbearing potential not protected by highly-effective contraceptive
method(s) of birth control (as defined in the informed consent form and/or in a local
protocol addendum/amendment) over the study period and for at least 3 months following
the last dose of sarilumab, and/or who are unwilling or unable to be tested for
pregnancy.

- History of severe allergic or anaphylactic reactions to human, humanized, or murine
monoclonal antibodies (or to any of the excipients associated to sarilumab).

- Immunization with a live/attenuated vaccine within 4 weeks prior to Baseline.

- Stage III or IV cardiac failure according to the New York Heart Association
classification.

- History of previous gastrointestinal perforation or diverticulitis.

- Known active current/ recurrent infections (including but not limited to active
tuberculosis [TB] or history of incompletely treated TB and atypical mycobacterial
disease, hepatitis B and C, and herpes zoster). NOTE: in case of latent TB infection
the participant might be included if a subsequent appropriate anti TB treatment is
initiated since at least 3 weeks.

- Positive hepatitis B surface antigen, and/or positive total hepatitis B core antibody,
and/or positive hepatitis C antibody at the Screening visit.

- Evidence of serious uncontrolled concomitant disease, including severe uncontrolled
hypercholesterolemia or hypertriglyceridemia.

- Participants with any of the following laboratory abnormalities at the Screening or
Baseline visit:

- Hemoglobin <8.5 grams per deciliter.

- White blood cells <3000/cubic millimeter (mm^3).

- Absolute neutrophil count <2000/mm^3

- Absolute lymphocyte count <500/mm^3

- Platelet count <150 000 cells/mm^3

- Creatinine clearance <30 milliliter per minute.

- Aspartate aminotransaminase or Alanine aminotransaminase >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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: SARILUMAB

Drug: Azathioprine

Drug: Hydroxychloroquine

Drug: Sulfasalazine

Drug: Chloroquine

Drug: Leflunomide

Drug: Methotrexate

Primary Outcome(s)

Change From Baseline in Rheumatoid Arthritis Impact of Disease Total Score at Week 24 [Time Frame: Baseline, Week 24]

Secondary Outcome(s)

Disease Activity Score-28 for Rheumatoid Arthritis With Erythrocyte Sedimentation Rate (DAS28-ESR) at Baseline, Weeks 4, 12, and 24 [Time Frame: Baseline, Weeks 4, 12 and 24]

Duration of Morning Stiffness at Baseline, Weeks 4, 12, and 24 [Time Frame: Baseline, Weeks 4, 12 and 24]

Multidimensional Assessment of Thymic States (MAThyS) Scale Total Score at Baseline, Weeks 4, 12 and 24 [Time Frame: Baseline, Weeks 4, 12 and 24]

Number of Swollen Joints at Baseline, Weeks 4, 12, and 24 [Time Frame: Baseline, Weeks 4, 12 and 24]

Patient Global Assessment (PtGA) of Disease Activity Score by Visual Analog Scale (VAS) at Baseline, Weeks 4, 12 and 24 [Time Frame: Baseline, Weeks 4, 12 and 24]

Hospital Anxiety and Depression Scale (HADS): Anxiety (HADS-A) and Depression (HADS-D) Subscale Scores at Baseline, Weeks 4, 12, and 24 [Time Frame: Baseline, Weeks 4, 12 and 24]

Change From Baseline in Duration of Morning Stiffness at Weeks 4, 12, and 24 [Time Frame: Baseline, Weeks 4, 12 and 24]

Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Total Scores at Weeks 4, 12 and 24 [Time Frame: Baseline, Weeks 4, 12 and 24]

Change From Baseline in Rheumatoid Arthritis Impact of Disease Total Score at Weeks 4 and 12 [Time Frame: Baseline, Weeks 4 and 12]

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 [Time Frame: Weeks 12 and 24]

Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Total Scores at Baseline, Weeks 4, 12 and 24 [Time Frame: Baseline, Weeks 4, 12 and 24]

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Time Frame: Baseline up to end of study (up to 39.7 weeks)]

Change From Baseline in Erythrocyte Sedimentation Rate at Weeks 4, 12, and 24 [Time Frame: Baseline, Weeks 4, 12 and 24]

Change From Baseline in International Physical Activity Questionnaire Total Score at Weeks 4, 12 and 24 [Time Frame: Baseline, Weeks 4, 12 and 24]

International Physical Activity Questionnaire (IPAQ) Total Score at Baseline, Weeks 4, 12 and 24 [Time Frame: Baseline, Weeks 4, 12 and 24]

Number of Tender Joints at Baseline, Weeks 4, 12, and 24 [Time Frame: Baseline, Weeks 4, 12 and 24]

Change From Baseline in Disease Activity Score-28 for Rheumatoid Arthritis With Erythrocyte Sedimentation Rate at Weeks 4, 12, and 24 [Time Frame: Baseline, Weeks 4, 12 and 24]

Change From Baseline in Patient Global Assessment of Disease Activity Score by Visual Analog Scale at Weeks 4, 12, and 24 [Time Frame: Baseline, Weeks 4, 12 and 24]

Change From Baseline in Multidimensional Assessment of Thymic States Scale Total Score at Weeks 4, 12 and 24 [Time Frame: Baseline, Weeks 4, 12 and 24]

Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) Total Score at Baseline, Weeks 4, 12 and 24 [Time Frame: Baseline, Weeks 4, 12 and 24]

Change From Baseline in Number of Swelling Joints at Weeks 4, 12, and 24 [Time Frame: Baseline, Weeks 4, 12 and 24]

Change From Baseline in Number of Tender Joints at Weeks 4, 12, and 24 [Time Frame: Baseline, Weeks 4, 12 and 24]

Clinical Disease Activity Index (CDAI) Total Score at Baseline, Weeks 4, 12, and 24 [Time Frame: Baseline, Weeks 4, 12 and 24]

Number of Participants Achieving Low Disease Activity (DAS28 ESR Score <=3.2) and Remission (DAS28 ESR Score <2.6) at Weeks 12, and 24 [Time Frame: Weeks 12 and 24]

Erythrocyte Sedimentation Rate (ESR) at Baseline, Weeks 4, 12, and 24 [Time Frame: Baseline, Weeks 4, 12 and 24]

Change From Baseline in Clinical Disease Activity Index Total Score at Weeks 4, 12, and 24 [Time Frame: Baseline, Weeks 4, 12 and 24]

Change From Baseline in Hospital Anxiety and Depression Scale: Anxiety (HADS-A) and Depression (HADS-D) Subscale Scores at Weeks 4, 12 and 24 [Time Frame: Baseline, Weeks 4, 12 and 24]

Change From Baseline in Stanford Health Assessment Questionnaire Disability Index Total Score at Weeks 4, 12 and 24 [Time Frame: Baseline, Weeks 4, 12 and 24]

Rheumatoid Arthritis Impact of Disease Total Score at Baseline, Weeks 4, 12 and 24 [Time Frame: Baseline, Weeks 4, 12 and 24]

Secondary ID(s)

SARILL08755

2017-002951-27

U1111-1197-7699

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Regeneron Pharmaceuticals

Results

• Results available: Yes
• Date Posted: 10/08/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03449758