SarcoidosisPhase 3TAWISNCT05689879
Evaluation of TNF-alpha Antagonists (Infliximab) Withdrawal in Sarcoidosis
A Phase 3 study testing STOP arm in people with Sarcoidosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
In severe refractory sarcoidosis not responding to conventional immunosuppressive treatment, the third-line tumor necrosis factor (TNF)-alpha inhibitor infliximab is an alternative. Treatment duration is not known, although it has been suggested that relapse rates after withdrawal could be high. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoidosis
- What is being tested?
- STOP arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 23 Mar 2023to 12 Jan 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age superior or equal to 18 years
- Clinical and radiological presentation consistent with sarcoidosis
- Presence of non-caseating granulomas in at least one organ
Who cannot join
- Infliximab treatment for at least 6 months
- Steroid dosage < or equal to 10 mg/day for at least 6 months
- No activity of the disease (ePOST score 0) for at least 6 months
- Normal ACE (angiotensin converting enzyme) and serum calcemia level
- Signed informed consent
- Affiliated to the National French social security system
Show all 21Show fewer
- As infliximab is the most used TNF-alpha antagonists, we decided to include only patients treated with infliximab to increase the homogeneity.
- Pregnancy or breast-feeding
- Positive IGRA (Interferon Gamma Release Assays) test without previous antituberculous antibiotherapy
- Active infection
- Patients with moderate to severe heart failure (NYHA class III/ IV)
- Severe liver function disorders
- Alcoholism
- Severe kidney function disorders
- Pre-existing blood dyscrasias
- History of cancer in the 5 years before enrolment (except for cutaneous non melanoma cancers)
- Concurrent vaccination with live vaccines during therapy
- Inability to understand information about protocol
- Adult subject under legal protection or unable ton consent
- Absence of effective contraceptive method for men and women for duration of the study and 6 months after the end of participation
- Concomitant participation to another biomedical research (only Category 1 trial according to the french law)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of TNF-alpha Antagonists (Infliximab) Withdrawal in Sarcoidosis : a Prospective, Randomized, Controlled Trial
In severe refractory sarcoidosis not responding to conventional immunosuppressive treatment, the third-line tumor necrosis factor (TNF)-alpha inhibitor infliximab is an alternative. Treatment duration is not known, although it has been suggested that relapse rates after withdrawal could be high. We hypothesize that a prolonged course of TNF-alpha would be better for maintaining remission in sarcoidosis.
The population consists of histologically-proven adults sarcoidosis patients who were treated with infliximab and are in remission for at least 6 months with less than or equal to 10 milligrams of steroids (prednisone).
The present study is a phase 3, prospective, randomized, parallel groups, comparative, open-labelled 2 arms study superiority trial comparing a STOP to a REMAIN strategy. Patients will be randomized in the 2 groups in a 1:1 ratio.
Read the detailed description
The screening visit takes place between 60 days and until the baseline visit. The investigator will first check that the patient meets the inclusion criteria and does not present exclusion criteria. Before enrolment and randomization, all patients will receive comprehensive information and provide written consent.
Visit schedule:
- Baseline visit
- Follow-up Visits In the REMAIN arm: visits will be performed each 4-8 weeks depending on the infliximab interval. In the STOP arm, visits will be performed every 8 weeks, and in case of relapse (until M12+/- 2 weeks).
- Conditions
- Sarcoidosis
- Being tested
- STOP arm
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STOP armDrug
Also called TNF-alpha antagonists withdrawal
TNF-alpha antagonists withdrawal
| Study group | Role | What they receive |
|---|---|---|
| REMAIN arm | No intervention | Infliximab 3 to 5 mg/kg every 4-8 weeks, methotrexate 7.5-10 mg/week (or azathioprine 1 mg/Kg/day), steroids < or = 10 mg/day |
| STOP arm | Other | Methotrexate 0.3 mg/kg/week (or azathioprine 2 mg/kg/day (or 1 mg/kg/day if intermediary metabolism TMPT) (the dose of methotrexate will not exceed 25mg/kg/week wathever the weight of the patient), steroids < or = 10 mg/d Receives: Drug: STOP arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare 2 strategies of remission maintenance in patients who are in remission after infliximab administration
Percentage of patients with major relapse (reappearance or worsening of the disease with a ePOST score >0 and involvement of at least one major organ, a life-threatening situation, or both or relapse non responsive to mild treatment intensification) between enrolment and month 12.
Major organs are nervous system, heart, kidneys, muscles and lungs. Mild treatment intensification is defined by increasing the dosage of steroids at more than 20 milligrams/day.
The primary criterion will be assessed at each visit, in case of relapse and at the end of follow-up (M12).
Measured: 12 months
Secondary outcomes (9)
To compare the percentage of patients with minor relapses in the 2 groups
Percentage of patients with minor relapse (reappearance or worsening of the disease with a ePOST score > 0 not corresponding to the definition of major relapse) at months 12.
Measured: 12 months
To compare the rates of adverse events
All adverse events occurred between enrolment and Month 12, will be noted with special attention to infection, haematological toxicities and cancers.
Measured: 12 months
To determine which are the predictors of relapses
Percentage of patients with a previous heart involvement at inclusion
Measured: 12 months
To determine which are the predictives of relapses
Percentage of patients with nervous system involvement at inclusion
Measured: 12 months
To determine which are the relapsing predictors
Percentage of patients with hypermetabolism elsewhere consistent with sarcoidosis localization in positron emission tomography scan (PET scan) at inclusion
Measured: 12 months
To determine which are the prediction of relapses
Serum ACE (angiotensin converting enzyme) level at inclusion
Measured: 12 months
To compare results of Short Form (36) Health Survey in the 2 groups
Quality of life will be assessed by SF-36 (Short Form (36) Health Survey) at inclusion, Month 6 and Month 12 (score from 0 to 100, the higher score is the better).
Measured: 12 mois
Compare results of Nottingham scale of each groups
Quality of life will be assessed by Nottingham scale at inclusion, Month 6 and Month 12 (score from 0 to 38, the higher score is the worse) .
Measured: 12 mois
To compare results of Fatigue Assessment Scale in the 2 groups
Quality of life will be assessed by Fatigue Assessment Scale (FAS, Patel 2000) at inclusion, Month 6 and Month 12 (score from 10 to 50, the higher score is the worse) .
Measured: 12 mois
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start23 Mar 2023
- Primary completion12 Jan 2027 (estimated)
- Study completion12 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Infliximab stop Methotrexate (without exceed 25mg/kg/week) or azathioprine
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fleur COHEN AUBART, PHD, Study director, Internal Medicine Department 2 - Hôpital Pitié-Salpêtrière
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689879
- Sponsor's protocol ID
- P160922
- Acronym
- TAWIS
- Status last verified
- Apr 2026
- First submitted
- 2 May 2022
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of TNF-alpha Antagonists (Infliximab) Withdrawal in Sarcoidosis : a Prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT05689879
- Acronym / sponsor ID
- TAWIS / P160922
- Conditions
- Sarcoidosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- 12 Jan 2027 (estimated)
- Study completion
- 12 Jan 2027 (estimated)
- First posted
- 19 Jan 2023 (actual)
- 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.
In severe refractory sarcoidosis not responding to conventional immunosuppressive treatment, the third-line tumor necrosis factor (TNF)-alpha inhibitor infliximab is an alternative. Treatment duration is not known, although it has been suggested that relapse rates after withdrawal could be high. We hypothesize that a prolonged course of TNF-alpha would be better for maintaining remission in sarcoidosis.
The population consists of histologically-proven adults sarcoidosis patients who were treated with infliximab and are in remission for at least 6 months with less than or equal to 10 milligrams of steroids (prednisone).
The present study is a phase 3, prospective, randomized, parallel groups, comparative, open-labelled 2 arms study superiority trial comparing a STOP to a REMAIN strategy. Patients will be randomized in the 2 groups in a 1:1 ratio.
Detailed description
The screening visit takes place between 60 days and until the baseline visit. The investigator will first check that the patient meets the inclusion criteria and does not present exclusion criteria. Before enrolment and randomization, all patients will receive comprehensive information and provide written consent.
Visit schedule:
- Baseline visit
- Follow-up Visits In the REMAIN arm: visits will be performed each 4-8 weeks depending on the infliximab interval. In the STOP arm, visits will be performed every 8 weeks, and in case of relapse (until M12+/- 2 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Infliximab stop Methotrexate (without exceed 25mg/kg/week) or azathioprine
| Arm | Type | Receives |
|---|---|---|
| REMAIN arm | No intervention | –Infliximab 3 to 5 mg/kg every 4-8 weeks, methotrexate 7.5-10 mg/week (or azathioprine 1 mg/Kg/day), steroids < or = 10 mg/day |
| STOP arm | Other | Drug: STOP armMethotrexate 0.3 mg/kg/week (or azathioprine 2 mg/kg/day (or 1 mg/kg/day if intermediary metabolism TMPT) (the dose of methotrexate will not exceed 25mg/kg/week wathever the weight of the patient), steroids < or = 10 mg/d |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age superior or equal to 18 years
- Clinical and radiological presentation consistent with sarcoidosis
- Presence of non-caseating granulomas in at least one organ
Key exclusion criteria (21 listed)
- Infliximab treatment for at least 6 months
- Steroid dosage < or equal to 10 mg/day for at least 6 months
- No activity of the disease (ePOST score 0) for at least 6 months
- Normal ACE (angiotensin converting enzyme) and serum calcemia level
- Signed informed consent
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 |
|---|---|---|
| STOP armAlso: TNF-alpha antagonists withdrawalTNF-alpha antagonists withdrawal | Drug | STOP arm |
Primary outcome
To compare 2 strategies of remission maintenance in patients who are in remission after infliximab administration
Time frame: 12 months
Percentage of patients with major relapse (reappearance or worsening of the disease with a ePOST score >0 and involvement of at least one major organ, a life-threatening situation, or both or relapse non responsive to mild treatment intensification) between enrolment and month 12. Major organs are nervous system, heart, kidneys, muscles and lungs. Mild treatment intensification is defined by increasing the dosage of steroids at more than 20 milligrams/day. The primary criterion will be assessed at each visit, in case of relapse and at the end of follow-up (M12).
9 secondary outcomes
To compare the percentage of patients with minor relapses in the 2 groups
Time frame: 12 months
To compare the rates of adverse events
Time frame: 12 months
To determine which are the predictors of relapses
Time frame: 12 months
To determine which are the predictives of relapses
Time frame: 12 months
To determine which are the relapsing predictors
Time frame: 12 months
To determine which are the prediction of relapses
Time frame: 12 months
To compare results of Short Form (36) Health Survey in the 2 groups
Time frame: 12 mois
Compare results of Nottingham scale of each groups
Time frame: 12 mois
To compare results of Fatigue Assessment Scale in the 2 groups
Time frame: 12 mois
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Fleur COHEN AUBART, PHD study director
Internal Medicine Department 2 - Hôpital Pitié-Salpêtrière
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing STOP arm in people with Sarcoidosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
To compare 2 strategies of remission maintenance in patients who are in remission after infliximab administration (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2026.