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This observational trial assesses the safety and efficacy of Gammanorm® in autoimmune diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients Receiving Gammanorm® | Patients Receiving Gammanorm® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gammanorm | Drug | Patients already receiving Gammanorm will be observed over the course of 2 years every 3 months. Gammanorm will be given standard of care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| APHP - Pitie Salpetriere | Paris | 75651 | France | |||
| Chu de Rouen - Bois Guillaume |
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| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| 24 months |
| 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 |
| 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 |
| 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 |
| 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 |
| Evaluate treatment compliance | Evaluate treatment compliance in terms of number of infusions per week | 24 months |
| Evaluate reasons for stopping the treatment | Evaluate reasons for stopping the treatment by categorizing across the study the reasons subjects stopped treatment. | 24 months |
| 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 |
| 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 |
| Rouen |
| 76031 |
| France |
| CHU de la Martinique- Hopital Pierre Zobda Quitman | Fort-de-France | 97261 | Martinique |