Rheumatoid ArthritisPhase 4STARANCT01793519
Stopping TNF Alpha Inhibitors in Rheumatoid Arthritis
A Phase 4 study testing Etanercept, Infliximab and Adalimumab in people with Rheumatoid Arthritis, run by Georgetown University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Etanercept, Infliximab and Adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 290 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2013to 30 Aug 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- Study personnel will evaluate participant eligibility using a checklist of inclusion and exclusion criteria as outlined below. Clinical information will be obtained from subjects by interview and from the medical record.
At the screening visit, potential participants will be included if:
- Age greater than or equal to 18 years
- Have RA, as defined by the 1987 revised American College of Rheumatology criteria
- In sustained clinical remission for the last 6 months while receiving treatment with either etanercept, infliximab, or adalimumab, and greater than or equal to 1 DMARD (methotrexate, hydroxychloroquine, sulfasalazine, leflunomide, minocycline, cyclosporine, azathioprine, gold, penicillamine). DAS28 should be less than 2.6 on each visit over the preceding 6 months, with at least one visit 2-4 months before enrollment. If there is no visit 6 months before enrollment, the nearest visit in the 6-12 month period before enrollment should be considered and have a DAS28 less than 2.6.
Potential participants will be excluded if:
- Had dose increase of anti-TNF agent or DMARD in the last 6 months
- Had change of anti-TNF agent or DMARD in the last 6 months
- Treated currently with golimumab or certolizumab
- Treated with greater than 10 mg of prednisone (or equivalent) daily in the last 6 months
- Treated with greater than 5 mg of prednisone (or equivalent) daily in the last 3 months
- Treated with intramuscular or intravenous corticosteroids in the last 6 months for RA activity
- Treated with anakinra, abatacept, or tocilizumab in the last 6 months
- Treated with rituximab in the last 12 months
- Treated with an investigational RA drug in the last 6 months
- Pregnant (or anticipate pregnancy during the study period) or lactating women
- Absence of documentation in the medical record of clinical remission for the last 6 months
- Unwilling to discontinue anti-TNF agent
- Absence of documentation of negative tuberculin skin test, negative QuantiFERON-TB Gold test, or treatment for latent tuberculosis prior to starting treatment with the anti-TNF agent
- Treatment of solid malignancy or non-melanoma skin cancer within the past 5 years, or any history of melanoma or hematologic or lymphoproliferative malignancy
- Absence of documentation of age-appropriate cancer screening at the time of randomization
- Absence of documentation of negative hepatitis B serologies, absence of completion of treatment for chronic hepatitis B, or absence of suppressive antiviral treatment
- Unable to provide informed consent
- Anticipate not being available or able to comply with the schedule of study visits
Study entry is not limited by gender or ethnicity. Children are excluded because inflammatory polyarthritis developing before age 16 is considered juvenile idiopathic arthritis and not RA. Patients who developed RA while age 17 would be eligible, but given the time needed to achieve remission, these patients would in most cases be 18 or older by the time they would meet other criteria for study entry.
Participants will largely be recruited from the practices of study investigators. To identify potential subjects, investigators may search rosters of patients in their practice for patients who meet the inclusion criteria. The number of patients screened and reasons for exclusion will be tabulated at each site. Subjects may also be recruited by physician referral. Information about the study will be mailed to local rheumatologists and posted on the NIAMS website. We do not anticipate self-referral of subjects but eligible self-referred subjects will not be excluded.
During the course of the study, enrollment of subjects treated with a particular anti-TNF agent may be suspended or terminated to permit adequate representation of patients treated with each of the 3 anti-TNF medications, due to problems procuring medication, or due to other unforeseen issues.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
About this study
Official title: Stopping Tumor Necrosis Factor-Alpha Inhibitors in Rheumatoid Arthritis (STARA) Clinical Trial
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.
Read more
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.
Read the detailed description
Remission of rheumatoid arthritis (RA) is an achievable goal with currently available medications, including the anti-tumor necrosis factor (anti-TNF) agents. However, it is uncertain if patients with RA in clinical remission while treated with anti-TNF agents and background disease-modifying antirheumatic drugs (DMARD) would remain in remission if anti-TNF therapy was stopped. If remission can be sustained off anti-TNF agents, then patients may be spared the potential toxicity and costs of these medications.
The Stopping Anti-Tumor Necrosis Factor Agents in Rheumatoid Arthritis (STARA) study is a multicenter, randomized, double-blind, placebo-controlled noninferiority trial that will test differences in time to relapse between patients with RA in remission who discontinue anti-TNF agents and patients with RA in remission who continue anti-TNF agents. The secondary objectives of the study are: 1) to determine if discontinuation of anti-TNF agents results in a difference in progression of joint damage on radiographs; 2) to determine if discontinuation of anti-TNF agents results in a difference in physical function, and 3) to identify predictors of relapse.
Eligible subjects will have RA in remission for at least six months while taking etanercept, infliximab, or adalimumab. An eight-week run-in period prior to randomization will be used to confirm remission. Subjects will then be randomized in a 2:1 ratio to receive one of two blinded treatments: 1) matching placebo or 2) their currently used anti-TNF agent, respectively. All subjects will maintain their current background DMARD. Clinical assessments will be performed every 12 weeks. The primary outcome is 48-week relapse-free status. Secondary outcomes include change from baseline radiographic joint damage score at 48 weeks and 100 weeks, and change from baseline physical function score at 48 weeks. Subjects who relapse before week 48 will discontinue study medication and receive treatment through their rheumatologist. Blinded treated will end at week 48 and subjects will be followed for 52 additional weeks. This study will provide important new information on the best treatment approach for patients with RA in remission.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Etanercept, Infliximab, Adalimumab, Placebo
- Keywords
- Rheumatoid Arthritis, Autoimmune Diseases, Anti-TNF
- Medical subject headings
- Arthritis, Rheumatoid, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
Also called Enbrel
Subcutaneous
InfliximabDrug
Also called Remicade
Infusion
AdalimumabDrug
Also called Humira
Subcutaneous
PlaceboDrug
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| Anti-tumor necrosis factor agent | Active comparator | Anti-TNF agent - etanercept, infliximab, adalimumab - administered parentally at standard dosage and frequencies Receives: Drug: Etanercept; Drug: Infliximab; Drug: Adalimumab |
| Placebo | Placebo comparator | Administered appropriately to active comparator Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission by Disease Activity Score - 28 over 48 weeks
Measured: 48 weeks
Secondary outcomes (2)
Change in Health Assessment Questionnaire Disability Index over 48 weeks
Measured: 48 weeks
Change in Sharp-van der Heijde radiographic score over 48 weeks
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startJan 2013
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), University of Maryland, Baltimore, Washington D.C. Veterans Affairs Medical Center, Medstar Health Research Institute, Patient-Centered Outcomes Research Institute, Arthritis and Pain Associates of PG County, Arthritis & Rheumatism Associates, P.C., Rheumatology Associates of Baltimore, L.L.C., The Arthritis Clinic of Northern Virginia, P.C., Arthritis and Rheumatic Disease Associates, P.C.
- Responsible party
- Sponsor
- Investigators
- Michael M Ward, M.D., Principal investigator, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Florina Constantinescu, MD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01793519
- Sponsor's protocol ID
- CER-1402-10522
- Other IDs
- 13-AR-0056, CER-1402-10522
- Acronym
- STARA
- Status last verified
- Feb 2024
- First submitted
- 14 Feb 2013
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Choy EH, Panayi GS. Cytokine pathways and joint inflammation in rheumatoid arthritis. N Engl J Med. 2001 Mar 22;344(12):907-16. doi: 10.1056/NEJM200103223441207. No abstract available.
PubMed 11259725Lawrence RC, Helmick CG, Arnett FC, Deyo RA, Felson DT, Giannini EH, Heyse SP, Hirsch R, Hochberg MC, Hunder GG, Liang MH, Pillemer SR, Steen VD, Wolfe F. Estimates of the prevalence of arthritis and selected musculoskeletal disorders in the United States. Arthritis Rheum. 1998 May;41(5):778-99. doi: 10.1002/1529-0131(199805)41:53.0.CO;2-V.
PubMed 9588729Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, Gabriel S, Hirsch R, Hochberg MC, Hunder GG, Jordan JM, Katz JN, Kremers HM, Wolfe F; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008 Jan;58(1):26-35. doi: 10.1002/art.23176.
PubMed 18163497Ward MM, Weinstein A, Alejandro-Silva P, Matsumoto AK, Konatalapalli RM, Stahl N, Kerr GS, Mikdashi J, Kempf PW, Shah NR, Danielides S, Ghafouri M, Olenginski TP, Fike A, Constantinescu F. Patient-Reported Outcomes Following Discontinuation Of Tumor Necrosis Factor Inhibitors In Rheumatoid Arthritis Remission/Low Disease Activity: A Randomized Placebo-Controlled Trial. J Rheumatol. 2026 Sep 15:jrheum.2026-0356. doi: 10.3899/jrheum.2026-0356. Online ahead of print.
PubMed 42744394Ward MM, Weinstein A, Alejandro-Silva P, Matsumoto AK, Konatalapalli R, Stahl N, Kerr GS, Mikdashi J, Kempf P, Shah NR, Danielides S, Ghafouri M, Olenginski TP, Fike A, Balyozova-Dinkov D, Thiele R, Yao L, Paul S, Constantinescu F. Discontinuation versus continuation of maintenance treatment with tumor necrosis factor inhibitors in patients with rheumatoid arthritis with low disease activity or remission: A randomized double-blind placebo-controlled trial. Semin Arthritis Rheum. 2025 Dec;75:152831. doi: 10.1016/j.semarthrit.2025.152831. Epub 2025 Sep 17.
PubMed 41045868
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stopping Tumor Necrosis Factor-Alpha Inhibitors in Rheumatoid Arthritis (STARA) Clinical Trial
- ClinicalTrials.gov ID
- NCT01793519
- Acronym / sponsor ID
- STARA / CER-1402-10522
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Autoimmune Diseases, Anti-TNF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), University of Maryland, Baltimore, Washington D.C. Veterans Affairs Medical Center, Medstar Health Research Institute, Patient-Centered Outcomes Research Institute, Arthritis and Pain Associates of PG County, Arthritis & Rheumatism Associates, P.C., Rheumatology Associates of Baltimore, L.L.C., The Arthritis Clinic of Northern Virginia, P.C., Arthritis and Rheumatic Disease Associates, P.C.
- Study start
- Jan 2013
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 15 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Remission of rheumatoid arthritis (RA) is an achievable goal with currently available medications, including the anti-tumor necrosis factor (anti-TNF) agents. However, it is uncertain if patients with RA in clinical remission while treated with anti-TNF agents and background disease-modifying antirheumatic drugs (DMARD) would remain in remission if anti-TNF therapy was stopped. If remission can be sustained off anti-TNF agents, then patients may be spared the potential toxicity and costs of these medications.
The Stopping Anti-Tumor Necrosis Factor Agents in Rheumatoid Arthritis (STARA) study is a multicenter, randomized, double-blind, placebo-controlled noninferiority trial that will test differences in time to relapse between patients with RA in remission who discontinue anti-TNF agents and patients with RA in remission who continue anti-TNF agents. The secondary objectives of the study are: 1) to determine if discontinuation of anti-TNF agents results in a difference in progression of joint damage on radiographs; 2) to determine if discontinuation of anti-TNF agents results in a difference in physical function, and 3) to identify predictors of relapse.
Eligible subjects will have RA in remission for at least six months while taking etanercept, infliximab, or adalimumab. An eight-week run-in period prior to randomization will be used to confirm remission. Subjects will then be randomized in a 2:1 ratio to receive one of two blinded treatments: 1) matching placebo or 2) their currently used anti-TNF agent, respectively. All subjects will maintain their current background DMARD. Clinical assessments will be performed every 12 weeks. The primary outcome is 48-week relapse-free status. Secondary outcomes include change from baseline radiographic joint damage score at 48 weeks and 100 weeks, and change from baseline physical function score at 48 weeks. Subjects who relapse before week 48 will discontinue study medication and receive treatment through their rheumatologist. Blinded treated will end at week 48 and subjects will be followed for 52 additional weeks. This study will provide important new information on the best treatment approach for patients with RA in remission.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-tumor necrosis factor agent | Active comparator | Drug: Etanercept, Drug: Infliximab, Drug: AdalimumabAnti-TNF agent - etanercept, infliximab, adalimumab - administered parentally at standard dosage and frequencies |
| Placebo | Placebo comparator | Drug: PlaceboAdministered appropriately to active comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtanerceptAlso: EnbrelSubcutaneous | Drug | Anti-tumor necrosis factor agent |
| InfliximabAlso: RemicadeInfusion | Drug | Anti-tumor necrosis factor agent |
| AdalimumabAlso: HumiraSubcutaneous | Drug | Anti-tumor necrosis factor agent |
| PlaceboMatching Placebo | Drug | Placebo |
Primary outcome
Remission by Disease Activity Score - 28 over 48 weeks
Time frame: 48 weeks
2 secondary outcomes
Change in Health Assessment Questionnaire Disability Index over 48 weeks
Time frame: 48 weeks
Change in Sharp-van der Heijde radiographic score over 48 weeks
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Background: PubMed 11259725Choy EH, Panayi GS. Cytokine pathways and joint inflammation in rheumatoid arthritis. N Engl J Med. 2001 Mar 22;344(12):907-16. doi: 10.1056/NEJM200103223441207. No abstract available.
- Background: PubMed 9588729Lawrence RC, Helmick CG, Arnett FC, Deyo RA, Felson DT, Giannini EH, Heyse SP, Hirsch R, Hochberg MC, Hunder GG, Liang MH, Pillemer SR, Steen VD, Wolfe F. Estimates of the prevalence of arthritis and selected musculoskeletal disorders in the United States. Arthritis Rheum. 1998 May;41(5):778-99. doi: 10.1002/1529-0131(199805)41:53.0.CO;2-V.
- Background: PubMed 18163497Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, Gabriel S, Hirsch R, Hochberg MC, Hunder GG, Jordan JM, Katz JN, Kremers HM, Wolfe F; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008 Jan;58(1):26-35. doi: 10.1002/art.23176.
- Derived from this study: PubMed 42744394Ward MM, Weinstein A, Alejandro-Silva P, Matsumoto AK, Konatalapalli RM, Stahl N, Kerr GS, Mikdashi J, Kempf PW, Shah NR, Danielides S, Ghafouri M, Olenginski TP, Fike A, Constantinescu F. Patient-Reported Outcomes Following Discontinuation Of Tumor Necrosis Factor Inhibitors In Rheumatoid Arthritis Remission/Low Disease Activity: A Randomized Placebo-Controlled Trial. J Rheumatol. 2026 Sep 15:jrheum.2026-0356. doi: 10.3899/jrheum.2026-0356. Online ahead of print.
- Derived from this study: PubMed 41045868Ward MM, Weinstein A, Alejandro-Silva P, Matsumoto AK, Konatalapalli R, Stahl N, Kerr GS, Mikdashi J, Kempf P, Shah NR, Danielides S, Ghafouri M, Olenginski TP, Fike A, Balyozova-Dinkov D, Thiele R, Yao L, Paul S, Constantinescu F. Discontinuation versus continuation of maintenance treatment with tumor necrosis factor inhibitors in patients with rheumatoid arthritis with low disease activity or remission: A randomized double-blind placebo-controlled trial. Semin Arthritis Rheum. 2025 Dec;75:152831. doi: 10.1016/j.semarthrit.2025.152831. Epub 2025 Sep 17.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael M Ward, M.D. principal investigator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Florina Constantinescu, MD principal investigator
Georgetown University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Etanercept, Infliximab and Adalimumab in people with Rheumatoid Arthritis, run by Georgetown University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission by Disease Activity Score - 28 over 48 weeks (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01793519, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.