Comparison of two STrategies of glucocorticoid withdrawal in rheumatoid Arthritis patients

STAR Comparison of two STrategies of glucocorticoid withdrawal in rheumatoid Arthritis patients in low disease activity or Remission - STAR

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001618-18-FR

Enrollment

122

Registered

2016-06-09

Start date

2016-07-08

Completion date

Unknown

Last updated

2022-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

glucocorticoid withdrawal in rheumatoid arthritis MedDRA version: 19.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Trade Name: Prednisone Product Name: prednisone 5 mg Pharmaceutical Form: Capsule Trade Name: Prednisone Product Name: prednisone 4 mg Pharmaceutical Form: Capsule Pharmaceutical form of the plac

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patients who have fulfilled the 2010 ACR/EULAR criteria for RA for at least 6 months. • Aged 18 or over. • Treated with a stable dose of synthetic Disease Modifying Anti-Rheumatic Drugs (sDMARDs) and/or with a biological DMARD (bDMARD) for at least 3 months. • Who have been treated with oral prednisone or prednisolone for more than 6 months. • With a stable dose of 5mg/day of prednisone or prednisolone for at least 3 months. • And in remission or low disease activity as defined by a DAS28 under 3.2 for at least 3 months. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 122 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 122

Exclusion criteria

Exclusion criteria: • Any chronic condition that would need long-term corticoid use (chronic lung diseases, etc.). • 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. • Any GC joint injection within the last 3 months or scheduled in the next 3 months. • Any disease with GC contraindication. • Treatment with sultopride; injection of alive 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. .

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: To compare the proportion of patients : -who could only withdraw from prednisone. -with flares confirmed by the investigator. To compare the area under the curves of the FLARE questionnaire for the whole protocol. To compare the proportion of patients : -needing extra prednisone to control flares. -with intra-articular injections. - acute adrenal insufficiency. - a biological adrenal insufficiency. - in remission (i.e. DAS28 < 2.6) and the proportion of patients in LDA (2.6=DAS28=3.2) at 7 and 12 months. -with Severe “Serious” Adverse Events at 1, 4, 7 and 12 months. To compare: the HAQ medians between the two groups at 4, 7 and 12 months. to compare the RAID medians between the two groups at 4, 7 and 12 months. To compare the EQ-5D medians between the two groups at 4, 7 and 12 months. To compare the FACIT medians between the two groups at 4, 7 and 12 months. ;Primary end point(s): Proportion of patients who could withdraw from prednisone and hydrocortisone ;Timepoint(s) of evaluation of this end point: one year	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: To compare the proportion of patients : -who could only withdraw from prednisone. -with flares confirmed by the investigator. To compare the area under the curves of the FLARE questionnaire for the whole protocol. To compare the proportion of patients : -needing extra prednisone to control flares. -with intra-articular injections. - acute adrenal insufficiency. - a biological adrenal insufficiency. - in remission (i.e. DAS28 < 2.6) and the proportion of patients in LDA (2.6=DAS28=3.2) at 7 and 12 months. -with Severe “Serious” Adverse Events at 1, 4, 7 and 12 months. To compare: the HAQ medians between the two groups at 4, 7 and 12 months. to compare the RAID medians between the two groups at 4, 7 and 12 months. To compare the EQ-5D medians between the two groups at 4, 7 and 12 months. To compare the FACIT medians between the two groups at 4, 7 and 12 months. ;Primary end point(s): Proportion of patients who could withdraw from prednisone and hydrocortisone ;Timepoint(s) of evaluation of this end point: one year

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Secondary

Measure	Time frame
Secondary end point(s): • Proportion of patients who could only withdraw from prednisone. • Proportion of patients with flares confirmed by the investigator. • Area under the curves of the FLARE questionnaire for the whole protocol. • Proportion of patients needing extra prednisone to control flares. • Proportion of patients with intra-articular injections. • Proportion of patients with acute adrenal insufficiency. • Proportion of patients with a biological adrenal insufficiency. • Proportion of patients in remission (i.e. DAS28 < 2.6) and the proportion of patients in LDA (2.6=DAS28=3.2) at 7 and 12 months. • HAQ medians between the two groups at 4, 7 and 12 months. • RAID medians between the two groups at 4, 7 and 12 months. • EQ-5D medians between the two groups at 4, 7 and 12 months. • FACIT medians between the two groups at 4, 7 and 12 months. • Proportion of patients with Severe “Serious” Adverse Events. ;Timepoint(s) of evaluation of this end point: one month, 4 months, 6 months and one year	—

Measure

Time frame

Secondary end point(s): • Proportion of patients who could only withdraw from prednisone. • Proportion of patients with flares confirmed by the investigator. • Area under the curves of the FLARE questionnaire for the whole protocol. • Proportion of patients needing extra prednisone to control flares. • Proportion of patients with intra-articular injections. • Proportion of patients with acute adrenal insufficiency. • Proportion of patients with a biological adrenal insufficiency. • Proportion of patients in remission (i.e. DAS28 < 2.6) and the proportion of patients in LDA (2.6=DAS28=3.2) at 7 and 12 months. • HAQ medians between the two groups at 4, 7 and 12 months. • RAID medians between the two groups at 4, 7 and 12 months. • EQ-5D medians between the two groups at 4, 7 and 12 months. • FACIT medians between the two groups at 4, 7 and 12 months. • Proportion of patients with Severe “Serious” Adverse Events. ;Timepoint(s) of evaluation of this end point: one month, 4 months, 6 months and one year

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Countries

France

Contacts

Public Contacthuguet

CHU Toulouse

+33661778490

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026