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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03656640
Other study ID # IMMUNORM
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date November 23, 2016
Est. completion date December 9, 2019

Study information

Verified date March 2021
Source Octapharma
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Terminated
Enrollment 60
Est. completion date December 9, 2019
Est. primary completion date December 9, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Adult man or woman older than 18 years, 2. Patient with autoimmune disease such as CIDP, MMN, PM, DM, MI, ITP, NAM or any other off-label use of Gammanorm®, 3. Patient who has a prescription of Gammanorm® treatment for immunomodulation, 4. Patient accepting to participate in the study by oral consent after having received oral and written information on the study. Exclusion Criteria: 1. Patient treated with Gammanorm® for immune substitution, or other authorized use 2. Patient who refuses to participate in the study.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France APHP - Pitie Salpetriere Paris
France Chu de Rouen - Bois Guillaume Rouen
Martinique CHU de la Martinique- Hopital Pierre Zobda Quitman Fort-de-France

Sponsors (1)

Lead Sponsor Collaborator
Octapharma

Countries where clinical trial is conducted

France,  Martinique, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 SMOG score For patients with idiopathic thrombocytopenic purpura, efficacy will be assessed using the SMOG score. SMOG score : Bleeding manifestations are grouped into three major domains: skin (S), visible mucosae (M), and organs (O), with gradation of severity (SMOG). Each bleeding manifestation is assessed at the time of examination. Severity is graded from 0 to 3 or 4, with grade 5 for any fatal bleeding. 24 months
Secondary Rankin score For patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Multifocal motor neuropathy (MMN), efficacy will be assessed using the Rankin score 24 months
Secondary MRC For patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Multifocal motor neuropathy (MMN), efficacy will be assessed using the MRC. MRC (Medical research council) scale for testing muscle : The muscle scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle (5= Normal power , 0= No contraction visible or palpable). 24 months
Secondary ONLS For patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) and Multifocal motor neuropathy (MMN), efficacy will be assessed using the ONLS (overall neuropathy limitations score). Score ONLS (Overall Neuropathy Limitation Scale) : The OLNS focuses on upper and lower limb functions, and consists of a checklist for interviewing patients. It is scored from 0 to 5 on the upper limb section and from 0 to 7 on the lower limb section. A score of 0 indicates no limitations (the ceiling of the scale) and a score of 5 or 7 indicates no purposeful movement. 24 months
Secondary Muscular Testings and Myositis Functional Rating Scale For patients with inflammatory myopathies including dermatomyositis (DM), polymyositis (PM), inclusion body myositis (IBM), and autoimmune necrotizing myopathy (AINM), efficacy will be assessed using the muscular testings and myositis functional rating scale 24 months
Secondary Evaluate treatment compliance Evaluate treatment compliance in terms of number of infusions per week 24 months
Secondary Evaluate reasons for stopping the treatment Evaluate reasons for stopping the treatment by categorizing across the study the reasons subjects stopped treatment. 24 months
Secondary Patient satisfaction regarding Gammanorm Evaluate patient satisfaction with use of patient diaries where the patient will complete a questionnaire on Life Quality Index (LQI) 24 months
Secondary Patient Quality of Life regarding Gammanorm Evaluate patient quality of life with use of patient diaries where the patient will complete a questionnaire on quality of life (SF-12) 24 months
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