Response to Treatment With Intravenous Abatacept Adults With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Single-Open Label Study to Assess Changes in the Immune Profile in Response to Treatment With Intravenous Abatacept Adults With Rheumatoid Arthritis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drugs

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03700021
• Other study ID #: 18-01164
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 2019
• Est. completion date: November 2019

Study information

• Verified date: January 2019
• Source: New York University School of Medicine
• Contact: Tania Moin
• Phone: 212 263 9440
• Email: Tania.Moin[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The immune system of patients with Rheumatoid Arthritis (RA) is different from that of people who do not have RA. The purpose of this study is to examine immune cells and proteins before subjects start to take study medication and after subjects start treatment with an approved therapy for RA, abatacept that will be given in combination with Methotrexate and/or anti-rheumatic drugs (DMARDS) that are approved for the treatment of RA. This study will assess whether subjects have clinically responded to these medications. This assessment will also include a study of whether characteristics of the subject's immune system were changed by therapy with the study drug, abatacept.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men or women (not nursing or pregnant) over 18 years old who have active RA, defined as symptoms of RA prior to screening and have satisfied the ACR/EULAR 2010 criteria for the classification of RA prior to signing the informed consent.

• Subjects must have a DAS28CRP and CDAI assessment at screening and have at least 3 tender and at least 3 swollen joints (excluding distal interphalangeal joints) at screening and at Day 1. Patients must have at least moderate disease activity {CDAI>16); DAS28CRP (>4.0 )].

• Subjects must be naive to biologic DMARDs

• Subjects must be naive to targeted synthetic DMARDs such as tofacitinib, baricitinib, and investigational therapies for RA.

• Subjects receiving oral corticosteroids must be on a stable dose and at the equivalent of 10 mg prednisone daily for at least 4 weeks. Subjects may not receive an IM, IV or IA administration of a corticosteroid within 4 weeks prior to screening visit or initiation of therapy

• Patients with prior (including discontinued) therapy with Methotrexate and/or Hydroxychloroquine are permitted as long as they meet other inclusionary criteria.

• Subjects must have a DAS28CRP and CDAI at screening and have at least 3 tender and at least 3 swollen joints (excluding distal interphalangeal joints) at screening and at Day 1.

Exclusion Criteria:

• Subjects with autoimmune disease other than RA [e.g., psoriasis, systemic lupus erythematosus (SLE), vasculitis, seronegative spondyloarthritis, Inflammatory Bowel Disease, Sjogren's syndrome] or currently active fibromyalgia.

• Prior history of or current inflammatory joint disease other than RA (such as psoriatic arthritis, gout, reactive arthritis, Lyme disease).

Medical History and Concurrent Diseases

• Subjects who are prisoners, or compulsory detained.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Abatacept + csDMARD
Abatacept Time 0, Week 2, Month1,2,3, 4, & 5 IV administration on Abatacept (7 infusions). Abatacept will be initiated in concert with methotrexate or pre-existing csDMARD.

Locations

Country	Name	City	State
United States	New York University Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Activity measured using Health Assessment Questionnaire (HAQ)		12 Months