NCT01920919

Brief Summary

This trial examines whether low grade suppression of the initial inflammatory process of sarcoidosis by intervention with low-dose dexamethasone therapy achieves significant alleviation of (sub-)acute symptoms, improvement in quality of life, increase in work productivity, and whether this intervention prevents disease progression and reduces total health-care costs.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 12, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

3.2 years

First QC Date

August 7, 2013

Last Update Submit

November 18, 2014

Conditions

Sarcoidosis

Outcome Measures

Primary Outcomes (1)

  • Change in health-related quality of life versus baseline

    The primary outcome measure is the change in health-related quality of life compared with baseline.

    0, 3, 6, 12, 18, 24 months

Study Arms (2)

Dexamethasone 1 mg

EXPERIMENTAL

Dexamethasone 1 mg per day, for 180 days

Drug: Dexamethasone

Placebo

PLACEBO COMPARATOR

Placebo tablet, for 180 days

Drug: Placebo

Interventions

DexamethasoneDRUG
Dexamethasone 1 mg
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of sarcoidosis, confirmed by histology or cytology
  • Age 18-60 years
  • No affected organ requiring high dose immunosuppressive therapy
  • Short Form - 36 subscale physical functioning score \< 70 points

You may not qualify if:

  • Allergy to corticosteroids
  • Diagnosis of glaucoma, osteoporosis, history of fractures
  • History of gastric ulcera in the past 12 months
  • Current use of Non Steroidal Anti Inflammatory Drug without co-prescription of Proton Pump Inhibitor
  • Current use of carbamazepin, fenytoin, rifampicin
  • Obesity (BMI \> 30)
  • Pregnancy of lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Antonius Hospital

Nieuwegein, 3430 EM, Netherlands

RECRUITING

MeSH Terms

Conditions

Sarcoidosis

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Central Study Contacts

Roeland Vis

CONTACT

0031 30 609 2612r.vis@antoniusziekenhuis.nl

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hospital Pharmacist

Study Record Dates

First Submitted

August 7, 2013

First Posted

August 12, 2013

Study Start

June 1, 2013

Primary Completion

August 1, 2016

Last Updated

November 19, 2014

Record last verified: 2014-11

Locations

NL(1)