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  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
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REGIMS Multiple Sclerosis Immunotherapy Registry Version 2016 - Baseline Main Sheet

- 9/20/21 - 9 forms, 25 itemgroups, 116 items, 2 languages
Itemgroups: Ein-Ausschlusskriterien,Patientendaten,Krankheitsspezifische Angaben,EDSS-Score vor 12 Monaten,Heutige Scores der Funktionssysteme,Frühere verlaufsmodifizierende MS-Therapien,Aktuelle MS-Therapie,WeitereErkrankungen,Herz- / Kreislauferkrankungen,Stoffwechselerkrankungen,Infektionserkrankungen,Gastrointestinale Erkrankungen,Neurologische / Psychiatrische Erkrankungen,Allergien,Urogenitale Erkrankungen,Autoimmunerkrankungen,Blutbild / Labor,Allgemeine Symptome,Operation,Krebserkrankungen,Welche Therapien wurden aufgrund der Krebserkrankung durchgeführt?,Andere Erkrankung,Keine Vorerkrankungen aus diesen obigen Krankheitsgruppen/Erkrankungen bekannt,Schwangerschaft,Biologisches Material (z.B. Blut)
REGIMS is a registry of the administration, adverse events and benefit of immunotherapeutic agents in patients with Multiple Sclerosis. REGIMS is a project from the Institute of Epidemiology and Social Medicine of the University of Muenster, publication granted by Prof. Dr. Berger. For further information (in German), please view http://campus.uni-muenster.de/index.php?id=6075 or http://www.kompetenznetz-multiplesklerose.de/aktuelle-studien/regims. REGIMS ist ein Immuntherapieregister zur Verbesserung der Arzneimittelsicherheit in der Multiple Sklerose Therapie innerhalb des krankheitsbezogenen Kompetenznetzes MS. Das primäre Ziel von REGIMS ist die Erfassung der Häufigkeit, Charakteristika und Auswirkungen von Nebenwirkungen aktueller und neuer Immuntherapien in der klinischen Routinebehandlung der MS. Sekundäre Ziele sind die Auswertung von Faktoren, die a) mit Nebenwirkungen und b) mit guter Therapie-Adhärenz assoziiert sind. Optional können bei Zustimmung der Patienten Blutproben für die Biobank des KKNMS gesammelt werden. Patienten mit Multipler Sklerose (MS) weisen trotz des chronischen Verlaufs eine große Heterogenität klinischer Symptome, in Befunden der Bildgebung sowie pathophysiologischen Prozessen auf. Faktoren, die zur individuellen Krankheitsprognose beitragen sind kaum bekannt, jedoch hat die Einführung neuer Substanzen die Therapiemöglichkeiten der MS in den letzten Jahren deutlich erweitert. Die Anwendung sogenannter Immuntherapeutika (inklusive der neuen Substanzklasse der Biologika) bietet in der MS-Therapie eine Reihe von Chancen, birgt aber auch Risiken.

Baseline Pregnancy Part 1

25 itemgroups 116 items

Follow Up Main Sheet

25 itemgroups 116 items

Follow Up Medication Change

25 itemgroups 116 items

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - IMD Report - Rheumatic Diseases; Systemic Lupus Erythematosus or Cutaneous Lupus; Sjogren's Syndrome (Report Final and Annex Report 2 Final)

- 11/2/20 - 1 form, 25 itemgroups, 95 items, 1 language
Itemgroups: Administrative,Rheumatic Diseases,Rheumatic Diseases - Signs and Symptoms,Rheumatic diseases - Other signs and symptoms,Rheumatic diseases - Other signs and symptoms ,Rheumatic diseases - Diagnostic Test Results,Rheumatic diseases - Other Diagnostic Test Results ,Rheumatic diseases - Other Diagnostic Test Results ,Rheumatic diseases - Other diagnostic Procedure,Systemic Lupus Erythematosus or Cutaneous Lupus,Systemic Lupus Erythematosus or Cutaneous Lupus - Signs and symptoms (supporting the final diagnosis),Systemic Lupus Erythematosus or Cutaneous Lupus - Other Signs and symptoms,Systemic Lupus Erythematosus or Cutaneous Lupus - Other Signs and symptoms ,Systemic Lupus Erythematosus or Cutaneous Lupus - Diagnostic Test Results,Systemic Lupus Erythematosus or Cutaneous Lupus - Other Diagnostic Test Results ,Systemic Lupus Erythematosus or Cutaneous Lupus - Other Diagnostic Test Results ,Systemic Lupus Erythematosus or Cutaneous Lupus - Other diagnostic Procedure ,Sjogren's Syndrome,Sjogren's Syndrome - Signs and symptoms (supporting the final diagnosis),Sjogren's Syndrome - Other Signs and symptoms ,Sjogren's Syndrome - Other Signs and symptoms ,Sjogren's Syndrome - Diagnostic Test Results ,Sjogren's Syndrome - Other Diagnostic Test Results ,Sjogren's Syndrome - Other Diagnostic Test Results ,Sjogren's Syndrome - Other diagnostic Procedure
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Screening - MAGE-A3 Expression Test; Tumor Sample (For Re-Test); MAGE-A3 Expression Re-Test; Prior Surgery; Prior Therapy (Annex Report 2 Final)

- 9/17/21 - 1 form, 9 itemgroups, 51 items, 1 language
Itemgroups: Administrative,MAGE-A3 Expression Test,Tumor Sample (For Re-Test),MAGE-A3 Expression Re-Test,Prior Surgery,Prior Surgery Type,Prior Surgery,Prior Therapy,Prior treatment with systemic immunosuppressants
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Eligibility Check (Annex Report 2 Final)

- 9/17/21 - 1 form, 4 itemgroups, 29 items, 1 language
Itemgroups: Administrative,Eligibility Check,Inclusion Criteria,Exclusion Criteria
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Eligibility Check

- 9/17/21 - 1 form, 4 itemgroups, 29 items, 1 language
Itemgroups: Administrative,Eligibility Check,Inclusion Criteria,Exclusion Criteria
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Screening - MAGE-A3 Expression Test; Tumor Sample (For Re-Test); MAGE-A3 Expression Re-Test; Prior Surgery; Prior Therapy

- 9/17/21 - 1 form, 8 itemgroups, 50 items, 1 language
Itemgroups: Administrative,MAGE-A3 Expression Test,Tumor Sample (For Re-Test),MAGE-A3 Expression Re-Test,Prior Surgery,Prior Surgery Type,Prior Therapy,Prior treatment with systemic immunosuppressants
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Laboratory Reference Ranges, Use of Human Samples by GSK, Investigator's Signature (Report Final and Annex Report 2 Final)

- 11/3/20 - 1 form, 8 itemgroups, 31 items, 1 language
Itemgroups: Administrative,Laboratory Reference Ranges,Laboratory Reference Ranges - Haematology,Laboratory Reference Ranges - Biochemistry,Laboratory Reference Ranges - Hepatic Function,Laboratory Reference Ranges - Renal Function ,Use of human samples by GSK,Investigator's Signature
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - IMD Report - Other relevant information, Investigator signature (Report Final and Annex Report 2 Final)

- 11/3/20 - 1 form, 3 itemgroups, 7 items, 1 language
Itemgroups: Administrative,Other relevant information (including evolution),Investigator Signature
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - IMD Report - Autoimmune Liver Diseases; Sarcoidosis; Other diseases (Report Final and Annex Report 2 Final)

- 11/3/20 - 1 form, 23 itemgroups, 85 items, 1 language
Itemgroups: Administrative,Autoimmune Liver Diseases,Autoimmune Liver Diseases - Signs and Symptoms,Autoimmune Liver Diseases - Other signs and symptoms,Autoimmune Liver Diseases - Other signs and symptoms ,Autoimmune Liver Diseases - Diagnostic Test Results,Autoimmune Liver Diseases - Other Diagnostic Test Results ,Autoimmune Liver Diseases - Other Diagnostic Test Results ,Autoimmune Liver Diseases - Other diagnostic Procedure,Sarcoidosis,Sarcoidosis - Signs and symptoms,Sarcoidosis - Other Signs and symptoms,Sarcoidosis - Other Signs and symptoms ,Sarcoidosis - Diagnostic Test Results,Sarcoidosis - Other Diagnostic Test Results ,Sarcoidosis - Other Diagnostic Test Results ,Sarcoidosis - Other diagnostic Procedure ,Other disease,Other disease - Signs and symptoms,Other disease - Diagnostic Test Results ,Other disease - Other Diagnostic Test Results ,Other disease - Other Diagnostic Test Results ,Other disease - Other diagnostic Procedure
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - IMD Report - (Glomerulo)Nephritis; Inflammatory Skin Diseases; Autoimmune Myocarditis (Report Final and Annex Report 2 Final)

- 11/3/20 - 1 form, 26 itemgroups, 97 items, 1 language
Itemgroups: Administrative,(Glomerulo)Nephritis,(Glomerulo)Nephritis - Signs and Symptoms,(Glomerulo)Nephritis - Other signs and symptoms,(Glomerulo)Nephritis - Other signs and symptoms ,(Glomerulo)Nephritis - Diagnostic Test Results,(Glomerulo)Nephritis - Other Diagnostic Test Results ,(Glomerulo)Nephritis - Other Diagnostic Test Results ,(Glomerulo)Nephritis - Other diagnostic Procedure,Inflammatory skin diseases,Inflammatory skin diseases - Signs and symptoms,Inflammatory skin diseases - Signs and symptoms (skin lesions),Inflammatory skin diseases - Other Signs and symptoms,Inflammatory skin diseases - Other Signs and symptoms ,Inflammatory skin diseases - Diagnostic Test Results,Inflammatory skin diseases - Other Diagnostic Test Results ,Inflammatory skin diseases - Other Diagnostic Test Results ,Inflammatory skin diseases - Other diagnostic Procedure ,Autoimmune Myocarditis,Autoimmune Myocarditis - Signs and symptoms,Autoimmune Myocarditis - Other Signs and symptoms ,Autoimmune Myocarditis - Other Signs and symptoms ,Autoimmune Myocarditis - Diagnostic Test Results ,Autoimmune Myocarditis - Other Diagnostic Test Results ,Autoimmune Myocarditis - Other Diagnostic Test Results ,Autoimmune Myocarditis - Other diagnostic Procedure
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - IMD Report - Idiopathic Thrombocytopenic Purpura; Pernicious Anaemia; Vasculitis (Report Final and Annex Report 2 Final)

- 11/3/20 - 1 form, 25 itemgroups, 91 items, 1 language
Itemgroups: Administrative,Idiopathic Thrombocytopenic Purpura,Idiopathic Thrombocytopenic Purpura - Signs and Symptoms,Idiopathic Thrombocytopenic Purpura - Other signs and symptoms,Idiopathic Thrombocytopenic Purpura - Other signs and symptoms ,Idiopathic Thrombocytopenic Purpura - Diagnostic Test Results,Idiopathic Thrombocytopenic Purpura - Other Diagnostic Test Results ,Idiopathic Thrombocytopenic Purpura - Other Diagnostic Test Results ,Idiopathic Thrombocytopenic Purpura - Other diagnostic Procedure,Pernicious Anaemia,Pernicious Anaemia - Signs and symptoms,Pernicious Anaemia - Other Signs and symptoms,Pernicious Anaemia - Other Signs and symptoms ,Pernicious Anaemia - Diagnostic Test Results,Pernicious Anaemia - Other Diagnostic Test Results ,Pernicious Anaemia - Other Diagnostic Test Results ,Pernicious Anaemia - Other diagnostic Procedure ,Vasculitis,Vasculitis - Signs and symptoms,Vasculitis - Other Signs and symptoms ,Vasculitis - Other Signs and symptoms ,Vasculitis - Diagnostic Test Results ,Vasculitis - Other Diagnostic Test Results ,Vasculitis - Other Diagnostic Test Results (i.e. Serological viral hepatic tests, Serological liver enzymes),Vasculitis - Other diagnostic Procedure
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - IMD Report - Coeliac Disease; Antiphospholipid Syndrome; Autoimmune Haemolytic Anaemia (Report Final and Annex Report 2 Final)

- 11/3/20 - 1 form, 25 itemgroups, 87 items, 1 language
Itemgroups: Administrative,Coeliac disease,Coeliac disease - Signs and Symptoms,Coeliac disease - Other signs and symptoms,Coeliac disease - Other signs and symptoms ,Coeliac disease - Diagnostic Test Results,Coeliac disease - Other Diagnostic Test Results ,Coeliac disease - Other Diagnostic Test Results ,Coeliac disease - Other diagnostic Procedure,Antiphospholipid Syndrome,Antiphospholipid Syndrome - Signs and symptoms (supporting the final diagnosis),Antiphospholipid Syndrome - Other Signs and symptoms,Antiphospholipid Syndrome - Other Signs and symptoms ,Antiphospholipid Syndrome - Diagnostic Test Results,Antiphospholipid Syndrome - Other Diagnostic Test Results ,Antiphospholipid Syndrome - Other Diagnostic Test Results ,Antiphospholipid Syndrome - Other diagnostic Procedure ,Autoimmune Haemolytic Anaemia,Autoimmune Haemolytic Anaemia - Signs and symptoms (supporting the final diagnosis),Autoimmune Haemolytic Anaemia - Other Signs and symptoms ,Autoimmune Haemolytic Anaemia - Other Signs and symptoms ,Autoimmune Haemolytic Anaemia - Diagnostic Test Results ,Autoimmune Haemolytic Anaemia - Other Diagnostic Test Results ,Autoimmune Haemolytic Anaemia - Other Diagnostic Test Results ,Autoimmune Haemolytic Anaemia - Other diagnostic Procedure
Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

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