Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03535402
Other study ID # RA-012018
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date June 1, 2018
Est. completion date December 30, 2020

Study information

Verified date August 2020
Source Gaylis, Norman B., M.D.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

This is a single site Phase III 48-week open-label study to evaluate the structural response of sarilumab 200 mg SC injection administered to active RA patients. Active RA is defined as having a Clinical Disease Activity Index (CDAI) >10.0. All patients will have had an inadequate response to MTX (treated with 12.5-20 mg/wk. for at least 3 months) and have had no prior exposure to biologic medications for RA. The MTX will be continued throughout the trial allowing for dose reduction at the Primary Investigator's discretion due to safety. There will be a total of twenty (20) patients enrolled into the trial.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date December 30, 2020
Est. primary completion date December 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sarilumab
SC administration of 200 mg twice a week

Locations

Country Name City State
United States AARDS Research, Inc Aventura Florida

Sponsors (1)

Lead Sponsor Collaborator
Gaylis, Norman B., M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Clinical Response To explore the clinical response of these patients from Baseline to Week 48 as measured by the Clinical Disease Activity Index (CDAI) score. CDAI =28 Swollen Joint Count+28 Tender Joint Count+Provider Global Assessment +Patient Global Assessment. Result Intrepretaion is Remission is <2.8 or equal to 2.8; Low Disease Activity is >2.8 to 10.0; Moderate Disease Activity is 10.0; High Disease Activity is >10.0 to 22.0 48 weeks
Secondary Compare Clinical and Structural Efficacy To compare the clinical using the CDAI score and structural outcomes using the Modified OMERACT-RAMRIS score at Week 48 and see if there is a disconnect between the two outcomes 48 weeks
See also
  Status Clinical Trial Phase
Completed NCT04226131 - MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics N/A
Completed NCT04171414 - A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis Phase 3
Completed NCT02833350 - Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA) Phase 2
Completed NCT04255134 - Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN) Phase 4
Recruiting NCT05615246 - Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
Completed NCT03248518 - Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases N/A
Completed NCT03514355 - MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms N/A
Recruiting NCT06005220 - SBD121, a Synbiotic Medical Food for RA Management N/A
Recruiting NCT05451615 - Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis Phase 3
Completed NCT05054920 - Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis N/A
Completed NCT02037737 - Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting N/A
Recruiting NCT04079374 - Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel Phase 3
Completed NCT02504268 - Effects of Abatacept in Patients With Early Rheumatoid Arthritis Phase 3
Recruiting NCT05496855 - Remote Care in People With Rheumatoid Arthritis N/A
Completed NCT05051943 - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Recruiting NCT06103773 - A Study of Single and Multiple Oral Doses of TollB-001 Phase 1
Recruiting NCT06031415 - Study of GS-0272 in Participants With Rheumatoid Arthritis Phase 1
Completed NCT05999266 - The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
Recruiting NCT05302934 - Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
Recruiting NCT04169100 - Novel Form of Acquired Long QT Syndrome Phase 4