Stopping TNF Alpha Inhibitors in Rheumatoid Arthritis
Status:
Unknown status
Trial end date:
2020-08-01
Target enrollment:
Participant gender:
Summary
Background:
- Rheumatoid arthritis (RA) is often treated with drugs known as tumor necrosis factor
(TNF) inhibitors, that can help decrease joint pain and swelling and can even result in
RA remission. However, TNF inhibitors may increase risk of serious infections or some
types of cancer.
- It is not clear if people whose RA has been in remission for a long time need to stay on
the TNF inhibitor to remain in remission. If they can stop taking the TNF inhibitor
without having their symptoms come back, they will be spared the side effects of these
medicines. Some studies have shown that people can stay in remission after stopping a
TNF inhibitor, but other studies have not confirmed it. Researchers want to see if
people with RA in remission on a TNF inhibitor can stay in remission without this
medicine. Also there may be a clinical, imaging (MRI, ultrasound), laboratory profile
that will help to determine which patients remain in remission after stopping these
drugs.
Objectives:
- To see whether RA remission can continue after discontinuing use of a TNF inhibitor.
- To determine if clinical, imaging and immunological measurements can predict which
participants will flare and which will remain in remission after discontinuing TNF
inhibitor.
Eligibility:
-Individuals at least 18 years of age who have RA that is being controlled with TNF
inhibitors. We plan to randomize 291 patients.
Design:
- The study has seven visits over about 2 years. Six visits occur in the first year of the
study, about 12 weeks apart. The final study visit is 1 year after the end of the
treatment phase.
- At the first visit, participants will be screened with a physical exam and medical
history. They will complete a questionnaire about their RA symptoms. A blood sample will
be collected. They will continue to take their RA medicines during this time.
- The second visit will repeat tests from the first visit. These tests will confirm that
the RA is in remission. Imaging studies will be performed on the hands, wrists, feet,
and their connected joints. After this visit, participants will stop taking their TNF
inhibitors and will start to have injections of a study drug. This drug will be either
the participant's original TNF inhibitor or a placebo.
- There will be follow-up visits at weeks 12, 24, and 36. Participants will have a medical
history and joint exam. They will also provide blood samples and answer questions about
their RA symptoms.
- At the sixth visit (week 48), participants will repeat the tests and imaging studies
from the second visit. They will stop taking the study injections.
- Continued RA treatment after this visit will be decided by the participant and his or
her rheumatologist. Participants may take any recommended medicine, including the TNF
inhibitor they had been taking before the study. They will also receive a questionnaire
to complete at home and mail back before the final study visit.
- At the final visit (week 100), participants will repeat the tests and imaging studies
from the second and sixth visits.
Phase:
Phase 4
Details
Lead Sponsor:
Georgetown University
Collaborators:
Arthritis & Rheumatism Associates, P.C. Arthritis and Pain Associates of PG County Arthritis and Rheumatic Disease Associates, P.C. Medstar Health Research Institute National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Patient-Centered Outcomes Research Institute Rheumatology Associates of Baltimore, L.L.C. The Arthritis Clinic of Northern Virginia, P.C. University of Maryland University of Maryland, College Park Washington D.C. Veterans Affairs Medical Center Washington Hospital Center