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Completed

NCT Number: NCT02997605

Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bordeaux University Hospital, Bordeaux, France

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

glucocorticoid

Drug

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.

Other names: Prednisone, Hydrocortisone

Primary outcomes

  1. 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.

Secondary outcomes

  1. proportion of patients who could withdraw from prednisone

    Time frame: one year after a progressive decrease of Glucocorticoids or hydrocortisone replacement

    To compare the proportion of patients who could withdraw from prednisone whatever the additional hydrocortisone associated treatment.

  2. proportion of patients with acute adrenal insufficiency

    Time frame: one year

    To compare the proportion of patients with acute adrenal insufficiency at one year between the two groups.

  3. proportion of patients with biological adrenal insufficiency

    Time frame: one year

    To compare the proportion of patients with biological adrenal insufficiency at one year between the two groups.

  4. proportion of patients needing extra prednisone to control flares

    Time frame: one year

    To compare the proportion of patients needing extra prednisone to control flares

  5. proportion of patients who have at least one flare confirmed by the investigator during the protocol.

    Time frame: one year

    To compare the proportion of patients who have at least one flare confirmed by the investigator during the protocol.

  6. area under the curve of means of the FLARE (Flare Assessment in Rheumatoid Arthritis)

    Time frame: one year

    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.

  7. proportion of patients in DAS28 remission and in DAS28 low disease activity

    Time frame: 7 and 12 months

    To compare the proportion of patients in DAS28 remission and in DAS28 low disease activity at 7 and 12 months between the groups.

  8. medians of Health Assessment Questionnaire (HAQ)

    Time frame: 4, 7 months and 1 year

    To compare the medians of HAQ at 4, 7 months and one year between the groups.

  9. medians of Rheumatoid Arthritis Impact of Disease (RAID)

    Time frame: 4, 7 months and 1 year

    To compare the medians of RAID at 4, 7 months and one year between the groups.

  10. medians of EuroQol 5-dimensional Descriptive system (EQ-5D)

    Time frame: 4, 7 months and 1 year

    To compare the medians of EQ-5D at 4, 7 months and one year between the groups.

  11. medians of Functional Assessment of Chronic Illness Therapy - Fatigue Scale FACIT-F)

    Time frame: 4, 7 months and 1 year

    To compare the medians of FACIT-F at 4, 7 months and one year between the groups.

  12. proportion of patients with Serious Adverse events

    Time frame: 1 year

    To compare the proportion of patients with Serious Adverse events at one year between the groups.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients in Low Disease Activity or Remission.

Acronym: STAR

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Dec 20, 2016
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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