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Eligibility Juvenile Idiopathic Arthritis NCT01667471

- 29.04.20 - 1 Formular, 2 Itemgruppen, 13 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Juvenile Idiopathic Arthritis Who Completed WA19977 Core Study; ODM derived from: https://clinicaltrials.gov/show/NCT01667471

Eligibility Juvenile Idiopathic Arthritis NCT01557452

- 29.04.20 - 1 Formular, 2 Itemgruppen, 14 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
An Open-Label Extension of the Dose Finding Study (DSC/08/2357/36) in Patients With Poly Juvenile Idiopathic Arthritis (JIA); ODM derived from: https://clinicaltrials.gov/show/NCT01557452

Eligibility Juvenile Idiopathic Arthritis NCT01434082

- 29.04.20 - 1 Formular, 2 Itemgruppen, 14 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
Sleep Patterns in Children With and Without Juvenile Idiopathic Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01434082

Eligibility Juvenile Idiopathic Arthritis NCT01230827

- 28.04.20 - 1 Formular, 2 Itemgruppen, 9 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS); ODM derived from: https://clinicaltrials.gov/show/NCT01230827

Eligibility Juvenile Idiopathic Arthritis (JIA) NCT01544114

- 28.04.20 - 1 Formular, 2 Itemgruppen, 10 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
A Safety Study of VIMOVO in Adolescents With Juvenile Idiopathic Arthritis (JIA); ODM derived from: https://clinicaltrials.gov/show/NCT01544114

Eligibility Inflammatory Rheumatism NCT02164214

- 20.04.20 - 1 Formular, 2 Itemgruppen, 17 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
Does Etanercept Influence Tweak Modulation of Inflammation During Inflammatory Rheumatisms (Psoriatic Arthritis and Rheumatoid Arthritis)?; ODM derived from: https://clinicaltrials.gov/show/NCT02164214

Eligibility Rheumatoid Arthritis NCT02219347

- 16.04.20 - 1 Formular, 2 Itemgruppen, 10 Datenelemente, 1 Sprache
Itemgruppen: Inclusion Criteria, Exclusion Criteria
Biomarkers of Remission in Rheumatoid Arthritis (BioRRA); ODM derived from: https://clinicaltrials.gov/show/NCT02219347

Efficacy of ofatumumab in adult patients with active rheumatoid arthritis with inadequate response to methotrexate NCT00611455 - Liver Imaging; Liver Biopsy; Subject Continuation; Electronically Transferred Lab Data

- 02.04.20 - 1 Formular, 4 Itemgruppen, 51 Datenelemente, 1 Sprache
Itemgruppen: Liver Imaging, Liver Biopsy, Subject Continuation, Electronically Transferred Lab Data
Study ID: 110635 Clinical Study ID: 110635 Study Title: A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy (FINAL ANALYSIS: follow-up period and cumulative safety data across the whole study) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00611455 Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ofatumumab, Placebo Study Indication: Arthritis, Rheumatoid

Efficacy of ofatumumab in adult patients with active rheumatoid arthritis with inadequate response to methotrexate NCT00611455 - Vital Signs prior to Infusion; Liver Events; Investigational Product (Liver); Pharmacokinetics (Liver); Alcohol Intake; Medical Conditions (Liver)

- 02.04.20 - 1 Formular, 9 Itemgruppen, 44 Datenelemente, 1 Sprache
Itemgruppen: Vital Signs - Prior to Infusion, Liver Events, Investigational Product (Liver), Pharmacokinetics (Liver), Alcohol intake, Medical Conditions (Liver), Drug related liver disease conditions, Other Liver disease conditions, Other medical conditions
Study ID: 110635 Clinical Study ID: 110635 Study Title: A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy (FINAL ANALYSIS: follow-up period and cumulative safety data across the whole study) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00611455 Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ofatumumab, Placebo Study Indication: Arthritis, Rheumatoid

Efficacy of ofatumumab in adult patients with active rheumatoid arthritis with inadequate response to methotrexate NCT00611455 - Status of Treatment Blind; Pregnancy Information; Pharmacogenetic Research Withdrawal of Consent; Study Conclusion; Infusion

- 31.03.20 - 1 Formular, 5 Itemgruppen, 15 Datenelemente, 1 Sprache
Itemgruppen: Status of Treatment Blind, Pregnancy Information, Pharmacogenetic Research Withdrawal of Consent, Study Conclusion, Infusion
Study ID: 110635 Clinical Study ID: 110635 Study Title: A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy (FINAL ANALYSIS: follow-up period and cumulative safety data across the whole study) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00611455 Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ofatumumab, Placebo Study Indication: Arthritis, Rheumatoid

Efficacy of ofatumumab in adult patients with active rheumatoid arthritis with inadequate response to methotrexate NCT00611455 - Concomitant Medication; Pre-Medication prior to Infusion; RA Concomitant Medications; Corticosteroid Injection; Methotrexate Concomitant Medications

- 31.03.20 - 1 Formular, 5 Itemgruppen, 67 Datenelemente, 1 Sprache
Itemgruppen: Concomitant Medications, Pre-Medication prior to Infusion, RA Concomitant Medications , Corticosteroid Injection, Methotrexate Concomitant Medications
Study ID: 110635 Clinical Study ID: 110635 Study Title: A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy (FINAL ANALYSIS: follow-up period and cumulative safety data across the whole study) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00611455 Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ofatumumab, Placebo Study Indication: Arthritis, Rheumatoid

Efficacy of ofatumumab in adult patients with active rheumatoid arthritis with inadequate response to methotrexate NCT00611455 - Early Withdrawal - ESR; PK Blood Sample; Biomarker Samples; Transcriptomic Research Sample Collection; Liver Events; Investigational Product Discontinuation

- 25.03.20 - 1 Formular, 6 Itemgruppen, 23 Datenelemente, 1 Sprache
Itemgruppen: ESR, PK Blood Sample - Point in Time Collection, Biomarker Samples , Transcriptomic Research Sample Collection Details , Liver Event Assessment , Investigational Product Discontinuation
Study ID: 110635 Clinical Study ID: 110635 Study Title: A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy (FINAL ANALYSIS: follow-up period and cumulative safety data across the whole study) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00611455 Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ofatumumab, Placebo Study Indication: Arthritis, Rheumatoid

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