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T-cell Co-stimulation Modulator

Abatacept for Rheumatoid Arthritis (RAMBA Trial)

Phase 4

Waitlist Available

Led By William Rigby, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects receiving oral corticosteroids must be on a stable dose equivalent to 10 mg prednisone daily for at least 4 weeks

Men or women (not nursing or pregnant) over 18 years old with active Rheumatoid Arthritis as per American College of Rheumatology/ European League Against Rheumatism 2010 criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 9

Awards & highlights

RAMBA Trial Summary

This trial will test the effects of a new drug on the immune system of adults with rheumatoid arthritis.

Who is the study for?

This trial is for adults over 18 with active Rheumatoid Arthritis who haven't used biologic or targeted synthetic DMARDs. Participants need at least moderate disease activity and a stable dose of oral corticosteroids. They must not have other autoimmune diseases, a history of certain infections, or be pregnant or breastfeeding.Check my eligibility

What is being tested?

The study tests how intravenous Abatacept affects the immune profile in Rheumatoid Arthritis patients naive to biologic DMARDs. It's an open-label study where all participants receive the drug without being compared to a placebo or another treatment.See study design

What are the potential side effects?

Abatacept may cause side effects like infection risk increase, headache, nausea, and infusion reactions. Since it modulates the immune system, there might also be a higher chance of developing respiratory issues like bronchitis.

RAMBA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been on a stable dose of steroids equivalent to 10 mg of prednisone daily for at least 4 weeks.

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I am over 18, not pregnant or nursing, and have active Rheumatoid Arthritis.

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I have at least 3 tender and 3 swollen joints, not including finger tip joints.

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I have not taken biologic or targeted synthetic drugs for my condition.

RAMBA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 9

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 9

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 9 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

CDAI Score

DAS-28 CRP Score

Secondary outcome measures

CDAI Score After Abatacept Hold

DAS-28 CRP Score After Abatacept Hold

Side effects data

From 2019 Phase 4 trial • 149 Patients • NCT01548768

Worsening Migraine

Mobitz II Heart Block

Angina

Atrial Tachycardia

Panic Attack

Thrombophlebitis

100%

80%

60%

40%

20%

Study treatment Arm

Patients - Cross Sectional (RA)

RA Patients - Pharmacotherapy Escalation (TNFi)

RA Patients - Pharmacotherapy Escalation (DMARD)

Healthy Volunteers

RAMBA Trial Design

1Treatment groups

Experimental Treatment

Group I: Abatacept plus DMARDExperimental Treatment2 Interventions

Abatacept will be used concomitantly with standard of care disease-modifying anti-rheumatic drugs (DMARDs), other than tumor necrosis factor (TNF) antagonists or Janus kinase (JAK) inhibitors. Intravenous (IV) Abatacept will be administered as a 30-minute IV infusion utilizing weight range-based dosing: Less than 60 kg: 500 mg 60 to 100 kg: 750 mg More than 100 kg: 1000 mg Following the initial IV Abatacept administration, an IV infusion will be given at Weeks 2 and 4 after the first infusion and every 4 weeks thereafter for a total of 7 Abatacept doses. Abatacept will be discontinued after 6 months in all patients. Patients who have flared or failed to achieve low disease activity at 6 months will exit the trial except for one post-study visit for lab work at 9 months. In patients who have achieved low disease activity, Abatacept will be held for 6 months or until a flare results while DMARD use is continued.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abatacept

2005

Completed Phase 4

~112150

DMARDs

2010

Completed Phase 4

~810

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,367 Previous Clinical Trials

839,736 Total Patients Enrolled

5 Trials studying Rheumatoid Arthritis

406 Patients Enrolled for Rheumatoid Arthritis

Dartmouth-Hitchcock Medical CenterOTHER

524 Previous Clinical Trials

2,543,316 Total Patients Enrolled

1 Trials studying Rheumatoid Arthritis

15 Patients Enrolled for Rheumatoid Arthritis

Bristol-Myers SquibbIndustry Sponsor

2,638 Previous Clinical Trials

4,128,489 Total Patients Enrolled

108 Trials studying Rheumatoid Arthritis

371,515 Patients Enrolled for Rheumatoid Arthritis

Media Library

Abatacept (T-cell Co-stimulation Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT03652961 — Phase 4

Rheumatoid Arthritis Research Study Groups: Abatacept plus DMARD

Rheumatoid Arthritis Clinical Trial 2023: Abatacept Highlights & Side Effects. Trial Name: NCT03652961 — Phase 4

Abatacept (T-cell Co-stimulation Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03652961 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the research objectives of this trial?

"According to the trial sponsor, Bristol-Myers Squibb, this clinical study seeks to measure primary outcomes over a 24 week period. These include responses of abatacept and conventional synthetic disease-modifying anti-rheumatic drugs in inducing low activity levels, as well as relationships between co-primary endpoints over time by dechallenge of Abatacept after induction at 24 weeks. Additionally, secondary outcomes are being assessed using RAPID3 questionnaire (scored 1-10), tender/swollen joint count represented through CDAI calculation , and Disease Activity Score based on CRP test results (CRP"

Answered by AI

Are there any other reports of research conducted with Disease-Modifying Anti-Rheumatic Drugs (DMARDs)?

"Currently, 34 clinical trials related to DMARDs are being conducted. Of those active studies, 8 have reached the third stage of development. Toronto is hosting most of these experiments but there are 771 other locations where research for this treatment regime is taking place."

Answered by AI

Has the FDA sanctioned the use of disease-modifying antirheumatic drugs?

"DMARDs have been approved, so it has achieved a security rating of 3."

Answered by AI

What primary purpose is DMARDs typically employed for?

"DMARDs have been shown to be a successful form of treatment for rheumatoid arthritis but can also help patients with psoriatic, polyarticular juvenile idiopathic and severe juvenile idiopathic arthritides."

Answered by AI

Are the doors currently open for participants to join this trial?

"For the present, this trial is not recruiting. Initially posted on June 2nd 2019 and last updated July 22 2022, prospective participants must seek other medical studies to join in lieu of this one. Thankfully there are 380 active clinical trials for those with rheumatoid arthritis, as well as 34 more specifically targeting DMARDs treatment interventions."

Answered by AI

What is the enrollment size for this clinical test?

"This study has currently halted participant recruitment; it was first posted on June 2nd 2019 and last updated July 22nd 2022. For those who are seeking other clinical trials, 380 studies for rheumatoid arthritis and 34 DMARD-related investigations have commenced enrolment."

Answered by AI

Recent research and studies

Epidemiologic ReviewsJournal

Epidemiology of Rheumatoid Arthritis: Update

HOCHBERG, MARC C., and TIMOTHY D. SPECTOR. 1990. “Epidemiology of Rheumatoid Arthritis: Update”. Epidemiologic Reviews. Oxford University Press (OUP). doi:10.1093/oxfordjournals.epirev.a036058.

Current Treatment Options in RheumatologyJournal

Co-stimulation Therapy in Rheumatoid Arthritis: Today and Tomorrow

Schiff, Michael. 2015. “Co-stimulation Therapy in Rheumatoid Arthritis: Today and Tomorrow”. Current Treatment Options in Rheumatology. Springer Science and Business Media LLC. doi:10.1007/s40674-015-0029-0.

Clinical Reviews in Allergy & ImmunologyJournal

Memory B Cells and Response to Abatacept in Rheumatoid Arthritis

Gazeau, Pierre, Guillermo Carvajal Alegria, Valérie Devauchelle-Pensec, Christophe Jamin, Julie Lemerle, Boutahar Bendaoud, Wesley H Brooks, Alain Saraux, Divi Cornec, and Yves Renaudineau. 2017. “Memory B Cells and Response to Abatacept in Rheumatoid Arthritis”. Clinical Reviews in Allergy & Immunology. Springer Science and Business Media LLC. doi:10.1007/s12016-017-8603-x.

Arthritis & RheumatologyJournal