NCT03656640

Brief Summary

This observational trial assesses the safety and efficacy of Gammanorm® in autoimmune diseases.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2016

Typical duration for all trials

Geographic Reach
2 countries

3 active sites

Status
terminated

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

November 23, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 30, 2017

Completed
9 months until next milestone

First Posted

Study publicly available on registry

September 4, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2019

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

3 years

First QC Date

November 30, 2017

Last Update Submit

March 9, 2021

Conditions

Autoimmune Diseases

Outcome Measures

Primary Outcomes (1)

  • Evaluate the safety of Gammanorm® in terms of adverse event rate in patients receiving the off-label treatment in immunomodulation.

    Evaluate the safety of Gammanorm® in terms of adverse event rate in patients receiving the off-label treatment in immunomodulation.

    24 months

Secondary Outcomes (9)

  • SMOG score

    24 months

  • Rankin score

    24 months

  • MRC

    24 months

  • ONLS

    24 months

  • Muscular Testings and Myositis Functional Rating Scale

    24 months

  • +4 more secondary outcomes

Study Arms (1)

Patients Receiving Gammanorm®

Patients Receiving Gammanorm®

Drug: Gammanorm

Interventions

GammanormDRUG

Patients already receiving Gammanorm will be observed over the course of 2 years every 3 months. Gammanorm will be given standard of care.

Patients Receiving Gammanorm®

Eligibility Criteria

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

Adult men and women over 18 prescribed Gammanorm with autoimmune disease or any other off-label use of Gammanorm who are willing to participate in the study

You may qualify if:

  • Adult man or woman older than 18 years,
  • Patient with autoimmune disease such as CIDP, MMN, PM, DM, MI, ITP, NAM or any other off-label use of Gammanorm®,
  • Patient who has a prescription of Gammanorm® treatment for immunomodulation,
  • Patient accepting to participate in the study by oral consent after having received oral and written information on the study.

You may not qualify if:

  • Patient treated with Gammanorm® for immune substitution, or other authorized use
  • Patient who refuses to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

APHP - Pitie Salpetriere

Paris, 75651, France

Location

Chu de Rouen - Bois Guillaume

Rouen, 76031, France

Location

CHU de la Martinique- Hopital Pierre Zobda Quitman

Fort-de-France, 97261, Martinique

Location

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2017

First Posted

September 4, 2018

Study Start

November 23, 2016

Primary Completion

December 9, 2019

Study Completion

December 9, 2019

Last Updated

March 10, 2021

Record last verified: 2021-03

Locations

FR(2)MA(1)