Measurement of the Structural Efficacy in Active RA Patients Treated With Sarilumab in Combination With MTX and Naive to Biologics

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03535402
• Date of registration: 09/05/2018
• Prospective Registration: Yes
• Primary sponsor: Gaylis, Norman B., M.D.
• Public title: Measurement of the Structural Efficacy in Active RA Patients Treated With Sarilumab in Combination With MTX and Naive to Biologics
• Scientific title: Measurement of the Structural Efficacy in Active Rheumatoid Arthritis (RA) Patients Treated With Sarilumab in Combination With Methotrexate (MTX) and Naive to Biologics as Measured by Low-field MRI Using a Modified OMERACT-RAMRIS Score.
• Date of first enrolment: June 1, 2018
• Target sample size: 20
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03535402
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- 1. Patient must be at least 18 years old at the screening visit. 2. Patient must be
able to understand the information provided to them and to give written Informed
Consent before any study-related procedures are performed.

3. Female patients must be either postmenopausal for at least 1 year, surgically
incapable of childbearing, or effectively practicing an acceptable method of
contraception (oral/parenteral/implantable hormonal contraceptives, IUD, or barrier
and spermicide). Abstinence only is not an acceptable method. Patients must agree to
use adequate contraception during the study and for 4 weeks after their last dose of
sarilumab. Male patients must agree to ensure they or their female partner(s) are
using adequate contraception during the study and for 4 weeks after the patient
receives their last dose of sarilumab.

4. Patients must have a diagnosis of adult-onset RA according to the ACR/EULAR (2010)
Rheumatoid Arthritis Classification Criteria.

5. Patients must be experiencing moderate to severe RA, have at least 4 tender and 4
swollen joints at screening and a CDAI score of >10.0 despite treatment with MTX
12.5-20 mg/wk.

6. Continuous treatment with MTX (12.5-20 mg/wk. orally or intramuscular) for at least
12 weeks prior to screening with a stable dose for the past 4 weeks.

7. A Baseline MRI must show the presence of osteitis, synovitis or erosions in the
hand or wrist.

8. Patients must be able and willing to comply with the requirements of the study
protocol.

Exclusion Criteria:

- 1. Patients who have a diagnosis of any other inflammatory arthritis (e.g., psoriatic
arthritis or ankylosing spondylitis) 2. Patients with exposure to biologic medications
for RA 3. Patients with a non-inflammatory type of arthritis (e.g. osteoarthritis or
fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere
with evaluation of the effect of study drug on the patient's primary diagnosis of RA
4. Patients with history of an infected joint prosthesis at any time with that
prosthesis still in situ 5. Patients who are not candidates for treatment with
sarilumab as defined by the US Package Insert.

1. NSAIDs /COX-2 inhibitors any change in treatment or dose-adjustment within 2
weeks prior to screening

2. Oral corticosteroids >10 mg daily within 4 weeks of baseline

3. IM/IV/IA corticosteroids any dose 28 days prior to baseline 6. Female patients
who are breast-feeding, pregnant, or plan to become pregnant during the trial or
within twelve weeks following last dose of study drug 7. Patients with a history
of chronic infection due to fungal, parasitic or mycotic pathogens during the
preceding year, recent serious or life-threatening infection within 6 months
(including herpes zoster), or any current sign or symptom that may indicate an
infection 8. Patients with active TB (or history of active TB), positive chest
X-ray for TB, or positive (defined as induration of = 5mm) PPD skin test,
positive QuantiFERON, or patients having close contact with an individual with
active TB. Patients having a PPD skin test = 5 mm or a positive QuantiFERON test
can enter the study, provided that active TB is excluded by chest x-Ray and
provided that they are adequately treated for latent TB (INH therapy) for 9
months and provided that appropriate treatment is initiated simultaneously with
the first administration of sarilumab 9 Patients at a high risk of infection
(e.g. leg ulcers, indwelling urinary catheter and persistent or recurrent chest
infections and patients who are permanently bedridden or wheelchair bound) 10.
Patients with a known allergy or intolerance to sarilumab 11. Prior or current
history of malignancy, including lymphoproliferative diseases, other than
adequately treated carcinoma in-situ of the cervix, nonmetastatic squamous cell
or basal cell carcinoma of the skin, within 5 years prior to randomization
(baseline) visit 12. Patients with a current or recent history of severe,
progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal,
endocrine, pulmonary, cardiac, neurological or cerebral disease 13. Patients with
class III or IV congestive heart failure according to the New York Heart
Association (NYHA) 1964 classification criteria 14. Patients with a history of,
or suspected, demyelinating disease of the central nervous system (e.g. multiple
sclerosis or optic neuritis) 15. Patients with any other condition (e.g.
clinically significant laboratory values) which in the Investigator's judgment
would make the patient unsuitable for inclusion in the study 16. Patients who
have a metal device affected by MRI (e.g., any type of electronic, mechanical, or
magnetic implant; cardiac pacemaker; aneurysm clip(s); implanted cardioverter
defibrillator; or a cochlear implant) 17. Patients who have a potential
ferromagnetic foreign body (metal slivers, metal shavings, other metal objects)
for which they have sought medical attention 18. Concurrent steroid use > 10 mg
daily for any concomitant disease 19. Subjects who are known to be HIV, Hepatitis
B or Hepatitis C positive 20. Any patient who has surgery within 4 weeks prior to
screening or with planned surgery during the course of the study 21. Patients
with a history of inflammatory bowel disease or severe diverticulitis or previous
gastrointestinal perforation 22. Patients with any of the following laboratory
abnormalities at the screening visit:

- Hemoglobin < 9.0 g/dL

- White blood cells (WBC) <3000/mm3

- Neutrophils < 2.0/mm3

- Platelet Count <150,000/mm3

- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 1.5 ULN
unless documented Gilbert's disease diagnosed by genetic testing

- Presence of severe uncontrolled hypercholesterolemia (>350 mg/dL) or hyper-

- triglyceridemia (>500 mg/dL)

- Bilirubin > ULN unless documented Gilbert's disease diagnosed by genetic
testing 23. Prior treatment with sarilumab 24. Treatment with any live or
attenuated vaccine within 3 months prior to the Randomization



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

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Sarilumab

Primary Outcome(s)

Structural Efficacy of Sarilumab [Time Frame: 48 week]

Secondary Outcome(s)

Compare Clinical and Structural Efficacy [Time Frame: 48 weeks]

Clinical Response [Time Frame: 48 weeks]

Secondary ID(s)

RA-012018

Source(s) of Monetary Support

Please refer to primary and secondary sponsors