RheumatoId ArthritisPhase 4STARNCT02997605
Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients
A Phase 4 study testing GlucoCorticoid in people with RheumatoId Arthritis, run by University Hospital, Toulouse at 17 sites in France.
Trial summary
The purpose of this study is to compare the proportion of patients who could withdraw from prednisone and hydrocortisone one year after a progressive decrease of GC (GC tapering) or a hydrocortisone replacement therapy in rheumatoid arthritis in remission or low disease activity. 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?
- GlucoCorticoid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 17 sitesFrance
- Study dates
- 31 Jan 2017to 27 Jan 2022
- 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
Who may be able to join
- Patients ≥ 18 years old.
- Fulfilling the 2010 American College of Rheumatology (ACR)/EULAR criteria for RA.
- Treated with a stable dose of Synthetic Disease Modifying Anti-Rheumatic Drugs (sDMARD) or Biological Disease Modifying Anti-Rheumatic Drug (bDMARD) for at least 3 months.
- Who have been treated with prednisone or prednisolone for at least 6 months.
- With a stable dose of prednisone or prednisolone of 5mg/day for at least 3 months.
- With a DAS28 ≤3.2 for at least 3 months.
- Patients with health insurance
- Patients who have signed a written informed consent form.
Who cannot join
- Any chronic condition that would need long term corticoid use (e.g. chronic lung diseases).
- Evidence of a flare within the last 3 months.
- Evidence of an allergy or intolerance to hydrocortisone or prednisone.
- Chronic idiopathic, or autoimmune clinical adrenal insufficiency.
- GC joint injections within the last 3 months or scheduled in the next 3 months.
- Any GC intake expected more than >5mg/day within the next 12 months.
Show all 17Show fewer
- Association with sultopride and with live vaccines
- Significant trauma or major surgery within the 3 months prior to the baseline visit.
- Scheduled surgery in the next 12 months.
- Fibromyalgia.
- Foreseeable poor compliance with the strategy.
- Patient with any condition that would prevent participation in the study and completion of the study procedures, including language limitation.
- Alcohol and/or drug misuse as determined by the investigator.
- Pregnancy or breastfeeding.
- Patient is not willing to sign the informed consent.
- Juridical Protection
- DAS28>3.2 after one month of a stable dose of prednisone 5 mg/day.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
Bordeaux University Hospital
Bordeaux
Brest University Hospital
Brest
Jean Rougier Hospital
Cahors
Clermont-Ferrand Hospital
Clermont-Ferrand
Bicêtre Hospital
Le Kremlin-Bicêtre
Lille Hospital
Lille
Limoges Hospital
Limoges
Montpellier Hospital
Montpellier
Pasteur Hospital
Nice
Orléans Hospital
Orléans
Bichat Hospital
Paris
Cochin Hospital
Paris
La Pitié-Salpétrière
Paris
Lyon Sud Hopsital
Pierre-Bénite
Saint-Etienne Hospital
Saint-Etienne
Strasbourg Hospital
Strasbourg
Hospital Pierre-Paul Riquet
Toujouse, 31059
About this study
Official title: Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients in Low Disease Activity or Remission.
The purpose of this study is to compare the proportion of patients who could withdraw from prednisone and hydrocortisone one year after a progressive decrease of GC (GC tapering) or a hydrocortisone replacement therapy in rheumatoid arthritis in remission or low disease activity.
Read the detailed description
French multicenter double-blind controlled parallel-group randomized clinical trial Phase IV assessing whether a hydrocortisone replacement therapy could increase the success rate of GC withdrawal at one year, in patients with Rheumatoid Arthritis in low disease activity or remission, in comparison to progressive decrease of GC (GC tapering).
- Conditions
- RheumatoId Arthritis
- Being tested
- GlucoCorticoid
- Keywords
- low disease activity, remission
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucoCorticoidDrug
Also called Prednisone, Hydrocortisone
After inclusion in the study, the first part is an open follow-up period where all patients will receive 5 mg of prednisone daily for one month. After one month, if patients still have a DAS28 ≤3.2, they will be randomized into two arms: Group 1: "GC tapering group" / Group 2: "Hydrocortisone replacement group".
After randomisation, there are four scheduled visits: M4, M7, M9 and M12. Patients withdrawing from GC therapy will be instructed, that if they start feeling unwell during or after the GC tapering protocol they should not taper the steroid dose any further, but contact the centre responsible for the protocol. If GC induced adrenal insufficiency is confirmed or strongly suspected, GC replacement will be secured using hydrocortisone.
| Study group | Role | What they receive |
|---|---|---|
| Glucocorticoid (GC) tapering | Active comparator | "GC tapering group": patients will be asked to taper prednisone taken every morning at 8.00 AM by decreasing the daily dose by 1 mg every month as soon as they are in remission or Low Disease Activity (LDA). In addition they will receive a placebo of 20 mg/day of hydrocortisone (10 mg at 8.00 AM, 10 mg at 12.00 AM) for 3 months then 10 mg/day (at 8.00 AM) of hydrocortisone placebo for 3 months before discontinuing the hydrocortisone placebo. Receives: Drug: GlucoCorticoid |
| Hydrocortisone replacer | Active comparator | "Hydrocortisone replacer group": patients will replace prednisone with 20 mg of hydrocortisone on a daily basis (10 mg at 8.00 AM, 10 mg at 12.00 AM) for 3 months then 10 mg daily (at 8.00 AM) for 3 months then stop as soon as they are in remission or LDA, as well as a prednisone placebo (at 8.00 AM) with a schedule to taper the prednisone placebo by 1mg/day every month until discontinuation. Receives: Drug: GlucoCorticoid |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients who could withdraw from prednisone and hydrocortisone at one year
To compare a prednisone tapering strategy to a hydrocortisone replacement strategy on the success rate of prednisone and hydrocortisone withdrawal at one year in Rheumatoid Arthritis patients in low disease activity or remission.
Measured: one year after a progressive decrease of Glucocorticoids or hydrocortisone replacement
Secondary outcomes (12)
proportion of patients who could withdraw from prednisone
To compare the proportion of patients who could withdraw from prednisone whatever the additional hydrocortisone associated treatment.
Measured: one year after a progressive decrease of Glucocorticoids or hydrocortisone replacement
proportion of patients with acute adrenal insufficiency
To compare the proportion of patients with acute adrenal insufficiency at one year between the two groups.
Measured: one year
proportion of patients with biological adrenal insufficiency
To compare the proportion of patients with biological adrenal insufficiency at one year between the two groups.
Measured: one year
proportion of patients needing extra prednisone to control flares
To compare the proportion of patients needing extra prednisone to control flares
Measured: one year
proportion of patients who have at least one flare confirmed by the investigator during the protocol.
To compare the proportion of patients who have at least one flare confirmed by the investigator during the protocol.
Measured: one year
area under the curve of means of the FLARE (Flare Assessment in Rheumatoid Arthritis)
To compare the area under the curve of the means of the FLARE (Flare Assessment in Rheumatoid Arthritis) at one year with a self-assessment questionnaire.
Measured: one year
proportion of patients in DAS28 remission and in DAS28 low disease activity
To compare the proportion of patients in DAS28 remission and in DAS28 low disease activity at 7 and 12 months between the groups.
Measured: 7 and 12 months
medians of Health Assessment Questionnaire (HAQ)
To compare the medians of HAQ at 4, 7 months and one year between the groups.
Measured: 4, 7 months and 1 year
medians of Rheumatoid Arthritis Impact of Disease (RAID)
To compare the medians of RAID at 4, 7 months and one year between the groups.
Measured: 4, 7 months and 1 year
medians of EuroQol 5-dimensional Descriptive system (EQ-5D)
To compare the medians of EQ-5D at 4, 7 months and one year between the groups.
Measured: 4, 7 months and 1 year
medians of Functional Assessment of Chronic Illness Therapy - Fatigue Scale FACIT-F)
To compare the medians of FACIT-F at 4, 7 months and one year between the groups.
Measured: 4, 7 months and 1 year
proportion of patients with Serious Adverse events
To compare the proportion of patients with Serious Adverse events at one year between the groups.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study start31 Jan 2017
- Primary completion27 Jan 2022
- Study completion27 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 University Hospital, ToulouseThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adeline RUYSSEN-WITRAND, MD, PhD, Study chair, University Hospital of Toulouse, Rheumatology CenterArnaud CONSTANTIN, MD, PhD, Study chair, University Hospital of Toulouse, Rheumatology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02997605
- Sponsor's protocol ID
- RC31/15/7824
- Other IDs
- 2016-001618-18, PHRC, 2016
- Acronym
- STAR
- Status last verified
- Feb 2022
- First submitted
- 15 Dec 2016
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ruyssen-Witrand A, Brusq C, Masson M, Bongard V, Salliot C, Poiroux L, Nguyen M, Roux CH, Richez C, Saraux A, Vergne-Salle P, Morel J, Flipo RM, Piperno M, Gottenberg JE, Marotte H, Soubrier M, Gossec L, Dieude P, Lassoued S, Zabraniecki L, Couture G, Boyer JF, Jamard B, Degboe Y, Constantin A. Comparison of two strategies of glucocorticoid withdrawal in patients with rheumatoid arthritis in low disease activity (STAR): a randomised, placebo- controlled, double-blind trial. Ann Rheum Dis. 2025 Jan;84(1):49-59. doi: 10.1136/ard-2024-226620. Epub 2025 Jan 2.
PubMed 39874233
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients in Low Disease Activity or Remission.
- ClinicalTrials.gov ID
- NCT02997605
- Acronym / sponsor ID
- STAR / RC31/15/7824
- Conditions
- RheumatoId Arthritis
- Keywords
- low disease activity, remission
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 31 Jan 2017 (actual)
- Primary completion
- 27 Jan 2022 (actual)
- Study completion
- 27 Jan 2022 (actual)
- First posted
- 20 Dec 2016 (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.
The purpose of this study is to compare the proportion of patients who could withdraw from prednisone and hydrocortisone one year after a progressive decrease of GC (GC tapering) or a hydrocortisone replacement therapy in rheumatoid arthritis in remission or low disease activity.
Detailed description
French multicenter double-blind controlled parallel-group randomized clinical trial Phase IV assessing whether a hydrocortisone replacement therapy could increase the success rate of GC withdrawal at one year, in patients with Rheumatoid Arthritis in low disease activity or remission, in comparison to progressive decrease of GC (GC tapering).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucocorticoid (GC) tapering | Active comparator | Drug: GlucoCorticoid"GC tapering group": patients will be asked to taper prednisone taken every morning at 8.00 AM by decreasing the daily dose by 1 mg every month as soon as they are in remission or Low Disease Activity (LDA). In addition they will receive a placebo of 20 mg/day of hydrocortisone (10 mg at 8.00 AM, 10 mg at 12.00 AM) for 3 months then 10 mg/day (at 8.00 AM) of hydrocortisone placebo for 3 months before discontinuing the hydrocortisone placebo. |
| Hydrocortisone replacer | Active comparator | Drug: GlucoCorticoid"Hydrocortisone replacer group": patients will replace prednisone with 20 mg of hydrocortisone on a daily basis (10 mg at 8.00 AM, 10 mg at 12.00 AM) for 3 months then 10 mg daily (at 8.00 AM) for 3 months then stop as soon as they are in remission or LDA, as well as a prednisone placebo (at 8.00 AM) with a schedule to taper the prednisone placebo by 1mg/day every month until discontinuation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients ≥ 18 years old.
- Fulfilling the 2010 American College of Rheumatology (ACR)/EULAR criteria for RA.
- Treated with a stable dose of Synthetic Disease Modifying Anti-Rheumatic Drugs (sDMARD) or Biological Disease Modifying Anti-Rheumatic Drug (bDMARD) for at least 3 months.
- Who have been treated with prednisone or prednisolone for at least 6 months.
- With a stable dose of prednisone or prednisolone of 5mg/day for at least 3 months.
Key exclusion criteria (17 listed)
- Any chronic condition that would need long term corticoid use (e.g. chronic lung diseases).
- Evidence of a flare within the last 3 months.
- Evidence of an allergy or intolerance to hydrocortisone or prednisone.
- Chronic idiopathic, or autoimmune clinical adrenal insufficiency.
- GC joint injections within the last 3 months or scheduled in the next 3 months.
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 |
|---|---|---|
| GlucoCorticoidAlso: Prednisone, HydrocortisoneAfter inclusion in the study, the first part is an open follow-up period where all patients will receive 5 mg of prednisone daily for one month. After one month, if patients still have a DAS28 ≤3.2, they will be randomized into two arms: Group 1: "GC tapering group" / Group 2: "Hydrocortisone replacement group". After randomisation, there are four scheduled visits: M4, M7, M9 and M12. Patients withdrawing from GC therapy will be instructed, that if they start feeling unwell during or after the GC tapering protocol they should not taper the steroid dose any further, but contact the centre responsible for the protocol. If GC induced adrenal insufficiency is confirmed or strongly suspected, GC replacement will be secured using hydrocortisone. | Drug | Glucocorticoid (GC) tapering, Hydrocortisone replacer |
Primary outcome
proportion of patients who could withdraw from prednisone and hydrocortisone at one year
Time frame: one year after a progressive decrease of Glucocorticoids or hydrocortisone replacement
To compare a prednisone tapering strategy to a hydrocortisone replacement strategy on the success rate of prednisone and hydrocortisone withdrawal at one year in Rheumatoid Arthritis patients in low disease activity or remission.
12 secondary outcomes
proportion of patients who could withdraw from prednisone
Time frame: one year after a progressive decrease of Glucocorticoids or hydrocortisone replacement
proportion of patients with acute adrenal insufficiency
Time frame: one year
proportion of patients with biological adrenal insufficiency
Time frame: one year
proportion of patients needing extra prednisone to control flares
Time frame: one year
proportion of patients who have at least one flare confirmed by the investigator during the protocol.
Time frame: one year
area under the curve of means of the FLARE (Flare Assessment in Rheumatoid Arthritis)
Time frame: one year
proportion of patients in DAS28 remission and in DAS28 low disease activity
Time frame: 7 and 12 months
medians of Health Assessment Questionnaire (HAQ)
Time frame: 4, 7 months and 1 year
medians of Rheumatoid Arthritis Impact of Disease (RAID)
Time frame: 4, 7 months and 1 year
medians of EuroQol 5-dimensional Descriptive system (EQ-5D)
Time frame: 4, 7 months and 1 year
medians of Functional Assessment of Chronic Illness Therapy - Fatigue Scale FACIT-F)
Time frame: 4, 7 months and 1 year
proportion of patients with Serious Adverse events
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Results publication: PubMed 39874233Ruyssen-Witrand A, Brusq C, Masson M, Bongard V, Salliot C, Poiroux L, Nguyen M, Roux CH, Richez C, Saraux A, Vergne-Salle P, Morel J, Flipo RM, Piperno M, Gottenberg JE, Marotte H, Soubrier M, Gossec L, Dieude P, Lassoued S, Zabraniecki L, Couture G, Boyer JF, Jamard B, Degboe Y, Constantin A. Comparison of two strategies of glucocorticoid withdrawal in patients with rheumatoid arthritis in low disease activity (STAR): a randomised, placebo- controlled, double-blind trial. Ann Rheum Dis. 2025 Jan;84(1):49-59. doi: 10.1136/ard-2024-226620. Epub 2025 Jan 2.
- 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.
Adeline RUYSSEN-WITRAND, MD, PhD study chair
University Hospital of Toulouse, Rheumatology Center
Arnaud CONSTANTIN, MD, PhD study chair
University Hospital of Toulouse, Rheumatology Center
17 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 GlucoCorticoid in people with RheumatoId Arthritis, run by University Hospital, Toulouse at 17 sites 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 8 inclusion and 17 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: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
proportion of patients who could withdraw from prednisone and hydrocortisone at one year (time frame: one year after a progressive decrease of Glucocorticoids or hydrocortisone replacement). 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 NCT02997605, which also lists 1 linked publication.
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 Nov 2025.