NCT00982332

Brief Summary

The study will examine the efficacy of a single intramuscular injection of betamethasone dipropionate/betamethasone sodium phosphate at the dose of 20mg/8mg (injection volume 4 ml) as an induction therapy in patients with polymyalgia rheumatica. Twenty patients will be randomized to receive an injection of betamethasone or placebo (isotonic NaCl solution) immediately after diagnosis. Both groups will receive the standard-of-care steroid therapy, starting from 10 mg of prednisone every day (qd), tapered down by 2.5 mg monthly if the disease is not active (scheduled monthly follow-ups by a rheumatologist). Primary outcome measures: the total cumulative dose of glucocorticosteroids and disease duration.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2010

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2009

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 23, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

July 20, 2010

Status Verified

July 1, 2010

Enrollment Period

1.5 years

First QC Date

September 15, 2009

Last Update Submit

July 18, 2010

Conditions

Polymyalgia Rheumatica

Keywords

polymyalgia rheumatica

Outcome Measures

Primary Outcomes (1)

  • a total dose of glucocorticoids used in the course of the disease

    12 months

Study Arms (2)

betamethasone

ACTIVE COMPARATOR

patients treated with a single intramuscular injection of betamethasone

Drug: BetamethasoneDrug: isotonic sodium chloride solution (placebo)

isotonic sodium chloride solution

PLACEBO COMPARATOR
Drug: isotonic sodium chloride solution (placebo)

Interventions

BetamethasoneDRUG

betamethasone dipropionate 20 mg + betamethasone sodium phosphate 8 md as a single intramuscular injection

Also known as: diprospan injection
betamethasone
isotonic sodium chloride solution (placebo)DRUG

4 ml intramuscular

betamethasoneisotonic sodium chloride solution

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • clinical diagnosis of polymyalgia rheumatica

You may not qualify if:

  • decompensated diabetes mellitus
  • decompensated arterial hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bnai Zion Medical Center

Haifa, 38041, Israel

RECRUITING

MeSH Terms

Conditions

Polymyalgia Rheumatica

Interventions

Betamethasonebetamethasone dipropionate, betamethasone sodium phosphate drug combinationSodium Chloride

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Central Study Contacts

Gleb Slobodin, MD

CONTACT

972-506267284gleb.slobodin@b-zion.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 15, 2009

First Posted

September 23, 2009

Study Start

March 1, 2010

Primary Completion

September 1, 2011

Study Completion

March 1, 2012

Last Updated

July 20, 2010

Record last verified: 2010-07

Locations

IL(1)