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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 belowSelect...
I have been on a stable dose of steroids equivalent to 10 mg of prednisone daily for at least 4 weeks.
Select...
I am over 18, not pregnant or nursing, and have active Rheumatoid Arthritis.
Select...
I have at least 3 tender and 3 swollen joints, not including finger tip joints.
Select...
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
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 • NCT015487681%
Worsening Migraine
1%
Mobitz II Heart Block
1%
Angina
1%
Atrial Tachycardia
1%
Panic Attack
1%
Thrombophlebitis
100%
80%
60%
40%
20%
0%
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
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,373 Previous Clinical Trials
841,099 Total Patients Enrolled
5 Trials studying Rheumatoid Arthritis
406 Patients Enrolled for Rheumatoid Arthritis
Dartmouth-Hitchcock Medical CenterOTHER
528 Previous Clinical Trials
2,541,351 Total Patients Enrolled
1 Trials studying Rheumatoid Arthritis
15 Patients Enrolled for Rheumatoid Arthritis
Bristol-Myers SquibbIndustry Sponsor
2,650 Previous Clinical Trials
4,130,807 Total Patients Enrolled
108 Trials studying Rheumatoid Arthritis
371,515 Patients Enrolled for Rheumatoid Arthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have or had an inflammatory joint disease that is not rheumatoid arthritis.I have not received a live vaccine in the last 3 months.I am at risk for tuberculosis.I have had cancer in the past 5 years.I am over 18 years old.I have taken a pregnancy test within 24 hours before starting the study drug, and it was negative.I have not had major surgery in the last 60 days.I have a history of frequent bacterial infections.I do not have demyelinating disorders, heart failure, or conditions that prevent TNF inhibitor use.My arthritis severity has been measured recently.I agree to follow the birth control requirements during the study.I cannot have 5 or more of my joints properly checked for swelling or tenderness.My health conditions are severe and getting worse.I have been on a stable dose of steroids equivalent to 10 mg of prednisone daily for at least 4 weeks.I choose not to have sex and will continue taking pregnancy tests.I am over 18, not pregnant or nursing, and have active Rheumatoid Arthritis.I have at least 3 tender and 3 swollen joints, not including finger tip joints.I have been treated with Methotrexate or Hydroxychloroquine and meet other study requirements.I am a man and will follow birth control advice if my partner can have children.I have not taken biologic or targeted synthetic drugs for my condition.
Research Study Groups:
This trial has the following groups:- Group 1: Abatacept plus DMARD
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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