NCT00898989

Brief Summary

Comparison of a group of 20 IBM patients with 20 controls matched on age, gender and weight.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

December 21, 2010

Status Verified

December 1, 2010

Enrollment Period

1 year

First QC Date

May 11, 2009

Last Update Submit

December 18, 2010

Conditions

Inclusion Body Myositis

Outcome Measures

Primary Outcomes (1)

  • muscle strength

    2 evaluations at an interval of 9 months

Secondary Outcomes (1)

  • immune response

    1 measure at inclusion

Study Arms (2)

Inclusion Body Myositis

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic

You may qualify if:

  • Age \> 18 years old
  • Written consent

You may not qualify if:

  • Current infection
  • Cancer within 1 year
  • Immune deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Pitié-Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Myositis, Inclusion Body

Condition Hierarchy (Ancestors)

MyositisMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 11, 2009

First Posted

May 12, 2009

Study Start

April 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

December 21, 2010

Record last verified: 2010-12

Locations

FR(1)