NCT00244166

Brief Summary

  1. 1.to investigate whether steroids are effective in ankylosing spondylitis
  2. 2.if steroids are effective to describe how quick they work

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
75

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2002

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

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

Study Start

First participant enrolled

May 1, 2002

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2005

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

September 11, 2006

Status Verified

September 1, 2006

First QC Date

October 25, 2005

Last Update Submit

September 7, 2006

Conditions

Ankylosing Spondylitis

Keywords

treatmentankylosing spondylitisprednisolonetrialsteroid

Outcome Measures

Primary Outcomes (1)

  • 50% improvement of BASDAI after 14 days of treatment

Secondary Outcomes (6)

  • Improvement of pain on a VAS 0 - 10

  • Decrease of CRP/ BSG

  • Number of swollen/tender joints

  • number of enthesitic localisations

  • improvement of function (BASFI)

  • +1 more secondary outcomes

Interventions

prednisoloneDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ankylosing spondylitis according to the modified NY criteria 1984
  • age between 18 and 70 years
  • insufficient response to therapy with NSAIDs
  • BASDAI \> 4
  • Previous therapy with DMARDs (such as sulfasalazine, methotrexate etc.) or steroids less than or equal to 7,5mg is allowed, should be discontinued or stable 4 weeks before study start
  • written informed consent

You may not qualify if:

  • Pregnancy or lactation
  • current severe infection or during the last 3 months
  • suspected opportunistic infection during the past 2 months (such as Herpes zoster, cytomegaly-, Pneumocystis carinii-infection), HIV-infection
  • Malignancies
  • severe cardial, renal, hematological, endocrinological, pulmonal, gastrointestinal (such as peptic ulcers) neurological, hepatic (viral or toxic hepatitis) concomitant disease, uncontrolled arterial hypertension remitting thrombosis, embolism
  • Diabetes mellitus or increased blood glucose test
  • uncontrolled glaucoma
  • active immunization during the past 2 weeks or planned for the next 8 weeks
  • pathologic laboratory test results: creatinine \>200 µmol/l, liver enzymes \> 2,5 fold, AP \>2,5 fold upper normal ranges
  • significant pathological changes during physical examination
  • clinical trial participation during the past 30 days before screening
  • intake of "hard drugs" (such as cocaine, heroin)
  • therapy with more than 7,5 mg prednisolone, intraarticular steroids during the past 4 weeks before study start
  • current application for retirement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Charité Campus Benjamin-Franklin Rheumatolgy

Berlin, 12200, Germany

RECRUITING

Immanuel Hospital Rheumatology

Berlin, 14109, Germany

RECRUITING

Rheumazentrum Ruhrgebiet

Herne, 44652, Germany

RECRUITING

Related Publications (1)

  • Haibel H, Fendler C, Listing J, Callhoff J, Braun J, Sieper J. Efficacy of oral prednisolone in active ankylosing spondylitis: results of a double-blind, randomised, placebo-controlled short-term trial. Ann Rheum Dis. 2014 Jan;73(1):243-6. doi: 10.1136/annrheumdis-2012-203055. Epub 2013 Apr 26.

    PMID: 23625982DERIVED

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Joachim Sieper, Prof.

    Charité Campus Benjamin-Franklin Rheumatology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joachim Sieper, Prof.

CONTACT

0049 30 8445joachim.sieper@charite.de

Hildrun Haibel, MD

CONTACT

0049 30 8445hildrun.haibel@charite.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 25, 2005

First Posted

October 26, 2005

Study Start

May 1, 2002

Study Completion

August 1, 2008

Last Updated

September 11, 2006

Record last verified: 2006-09

Locations

DE(3)