Stopping TNF Alpha Inhibitors in Rheumatoid Arthritis

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.

Conditions

• Rheumatoid Arthritis

Interventions

DRUG

Etanercept

Subcutaneous

DRUG

Infliximab

Infusion

DRUG

Adalimumab

Subcutaneous

DRUG

Placebo

Matching Placebo

Sponsors & Collaborators

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

  collaborator NIH

• University of Maryland, Baltimore

  collaborator OTHER

• Washington D.C. Veterans Affairs Medical Center

  collaborator FED

• Medstar Health Research Institute

  collaborator OTHER

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• Arthritis and Pain Associates of PG County

  collaborator UNKNOWN

• Arthritis & Rheumatism Associates, P.C.

  collaborator OTHER

• Rheumatology Associates of Baltimore, L.L.C.

  collaborator UNKNOWN

• The Arthritis Clinic of Northern Virginia, P.C.

  collaborator UNKNOWN

• Arthritis and Rheumatic Disease Associates, P.C.

  collaborator UNKNOWN

• Georgetown University

  lead OTHER

Principal Investigators

• Michael M Ward, M.D. · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

• Florina Constantinescu, MD · Georgetown University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-01-31

Primary Completion

2024-06-30

Completion

2024-08-30

Countries

• United States

Study Locations