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

NCT03535402 | Unknown Phase 3 FDA Drug

• 1 other identifier: RA-012018
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single site study to determine the structural efficacy of sarilumab when administered to biologic naive patients with active rheumatoid arthritis

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Structural Efficacy of Sarilumab

  To explore the structural efficacy of sarilumab on synovitis, osteitis, and joint erosions as measured by MRI in active RA patients who had an inadequate response to MTX using the change in the OMERACT RAMRIS score from Baseline to Week 48. Synovitis is graded 0-3 (normal, mild, moderate and severe) as estimated by thirds of the presumed maximum volume of enhancing tissue. Bone edema is graded by percentage volume (0-3),byt 33% volume increments) of the assessed bone. Bone erosion is graded by assessing percentage volume (1-10,by 10 % volume increments) of the assessed bone volume. There are multiple parameters for these measurements and the OMERACTguide has to be used to perform this analysis.

  48 week

Secondary Outcomes (2)

• Clinical Response

  48 weeks

• Compare Clinical and Structural Efficacy

  48 weeks

Study Arms (1)

open label treatment

OTHER

single arm with patients receiving 200 mg SC twice a week of sarilumab

Drug: Sarilumab

Interventions

Sarilumab DRUG

SC administration of 200 mg twice a week

open label treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. 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.
• \. Patients must have a diagnosis of adult-onset RA according to the ACR/EULAR (2010) Rheumatoid Arthritis Classification Criteria.
• \. 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.
• \. 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.
• \. A Baseline MRI must show the presence of osteitis, synovitis or erosions in the hand or wrist.
• \. Patients must be able and willing to comply with the requirements of the study protocol.

You may not qualify if:

• \. 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.
• NSAIDs /COX-2 inhibitors any change in treatment or dose-adjustment within 2 weeks prior to screening
• Oral corticosteroids \>10 mg daily within 4 weeks of baseline
• 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

Sponsors & Collaborators

• Gaylis, Norman B., M.D.: lead

Study Sites (1)

AARDS Research, Inc

Aventura, Florida, 33180, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

sarilumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: May 24, 2018
• Study Start: June 1, 2018
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: August 11, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)