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RECRUITINGINTERVENTIONAL

Corticosteroid Tapering in Sarcoidosis

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Sarcoidosis is an inflammatory condition affecting many different parts of the body but most commonly the lungs. It is not known what causes sarcoidosis. In some patients no treatment is needed but in other patients long term treatment may be required. One of the main medications used to manage this condition is corticosteroids. This medication has been shown to be very effective at reducing inflammation in this condition and many patients often remain on it for months to years. Unfortunately, there are many negative long-term side effects of corticosteroid use. This includes an increased risk of developing diabetes, reduced bone density, weight gain, high blood pressure and low muscle mass. Currently there are no guidelines for how steroids should be weaned in patients who have stable sarcoidosis. The investigators aim to undertake a study at the Royal Brompton Hospital which will be assessing two different steroid tapering regimens which will be allocated to participants in a randomised manner. This will be the first study to directly evaluate different steroid weaning regimens in sarcoidosis patients. The main aim of this study is to determine how many participants can reduce their prednisolone dose to less than 50% from their baseline dose. Additionally, the investigators will be recording how many participants require an increase in dose or an additional medication whilst on the prednisolone weaning regimen. The investigators will also see the tolerability of steroid withdrawal and assess for any symptoms of steroid withdrawal. In a small subset of participants the investigators will assess for any changes in body composition and muscle strength using bioelectrical impedance analysis and isometric muscle testing.

Who May Be Eligible (Plain English)

Who May Qualify: - Confirmed sarcoidosis by: (a) Histological diagnosis and/or (b) Multidisciplinary Team (MDT) diagnosis - Prednisolone 5-10mg/day for \> 6 months - Clinically stable disease for \> 6 months (no flares or dose escalation) - On or off second-line agent - \> 18 years old - Written willing to sign a consent form provided Who Should NOT Join This Trial: - Cardiac or neurosarcoidosis - Advanced pulmonary sarcoidosis defined as either: (a) composite physiological index (CPI) \> 40 (b) pulmonary hypertension - Active sarcoidosis flare or dose escalation in the past 6 months - Known adrenal insufficiency - Pregnancy or breastfeeding - Previous or current infliximab use Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Confirmed sarcoidosis by: (a) Histological diagnosis and/or (b) Multidisciplinary Team (MDT) diagnosis * Prednisolone 5-10mg/day for \> 6 months * Clinically stable disease for \> 6 months (no flares or dose escalation) * On or off second-line agent * \> 18 years old * Written informed consent provided Exclusion Criteria: * Cardiac or neurosarcoidosis * Advanced pulmonary sarcoidosis defined as either: (a) composite physiological index (CPI) \> 40 (b) pulmonary hypertension * Active sarcoidosis flare or dose escalation in the past 6 months * Known adrenal insufficiency * Pregnancy or breastfeeding * Previous or current infliximab use

Treatments Being Tested

DRUG

Standard prednisolone taper

If initial dose of prednisolone \> 5mg/day then dose will be reduced by 2.5mg/day (round to nearest feasible dose) every 4 weeks until reaching 5mg/day. From 5mg/day to reduce by 1mg/day every 6 weeks until 3mg/day. At 3mg/day a serum cortisol will be measured after 2 weeks. If cortisol \> 25nmol/L, then continue with the Meeran prednisolone taper protocol which is reducing by 1mg every 7 days.

DRUG

Fast prednisolone taper

If initial prednisolone dose \> 5mg/day then reduce by 2.5mg/day (round to nearest feasible dose) every 4 weeks until reaching 5mg/day. From 5mg/day to reduce by 1mg every 2 weeks until 3mg/day. At 3mg/day then measure serum cortisol after 2 weeks. If cortisol \> 25nmol/L then continue to taper by 1mg every 2 weeks. In this arm, patients will contacted over the phone every 2 weeks to provide support with the tapering regimen.

Locations (1)

Royal Brompton Hospital
London, United Kingdom