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Efficacy of ofatumumab in adult patients with active rheumatoid arthritis with inadequate response to methotrexate NCT00611455 - Early Withdrawal - Administrative; Pain Assessment VAS Score; Patient's Global Assessment of Arthritis Condition VAS Score; Physician's Global Assessment of Arthritis Condition VAS Score; Vital Signs; ECG; Neurological Examination

- 3/24/20 - 1 form, 7 itemgroups, 21 items, 1 language
Itemgroups: Administrative, Pain Assessment VAS Score , Patient's Global Assessment of Arthritis Condition VAS Score , Physician's Global Assessment of Arthritis Condition VAS Score, Vital Signs , ECG , Neurological Examination
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 - Unscheduled - PK Blood Sample; Tender Joint Count; Swollen Joint Count; Swollen/Tender Joint Count; Pain Assessment VAS Score; Patient's Global Assessment of Arthritis Condition VAS Score; Physician's Global Assessment of Arthritis Condition VAS Score

- 3/24/20 - 1 form, 13 itemgroups, 32 items, 1 language
Itemgroups: PK Blood Sample - Point in Time Collection , Tender Joint Count Page 1, Tender Joint Count Page 2 , Joint Assessor Initials - Joint Pain/Tenderness , Calculations - Joint Pain/Tenderness, Swollen Joint Count Page 1, Swollen Joint Count Page 2, Joint Assessor Initials - Joint Swelling , Calculations - Joint Swelling , Swollen/ Tender Joint Count, Pain Assessment VAS Score , Patient's Global Assessment of Arthritis Condition VAS Score , Physician's Global Assessment of Arthritis Condition VAS Score
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

Evaluation of Naproxen Sodium and Sumatriptan in Adolescent Subjects With Migraine and Healthy Adult Subjects NCT00989625 - Logs/ Repeats - Concomitant Medication; Electronically Transferred Lab Data; Vital Signs

- 8/11/19 - 1 form, 3 itemgroups, 22 items, 1 language
Itemgroups: Concomitant Medication, Electronically Transferred Lab Data, Vital signs
Study ID: 108504 Clinical Study ID: 108504 Study Title: An Open Label, Single Dose, Randomised, Parallel Group Pharmacokinetic Study to Evaluate a Combination Product Containing Naproxen Sodium and Sumatriptan in Adolescent Subjects With Migraine and Healthy Adult Subjects Administered at Three Doses. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00989625 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: This is a pharmacokinetic study (Treximet) Trade Name: Naproxen Sodium and Sumatriptan Study Indication: Migraine Disorders

Evaluation of Naproxen Sodium and Sumatriptan in Adolescent Subjects With Migraine and Healthy Adult Subjects NCT00989625 - Dose - Vital Signs (Pre-Dose - 2 HR); Vital Signs (2.5 - 8 HR)

- 8/8/19 - 1 form, 5 itemgroups, 13 items, 1 language
Itemgroups: Date of visit/assessment, Vital Signs (Pre-dose - 2 HR) - Dosing Date and Time, Vital Signs (Pre-dose - 2 HR), Vital Signs (2.5 - 8 HR) - Dosing Date and Time , Vital Signs (2.5 - 8 HR)
Study ID: 108504 Clinical Study ID: 108504 Study Title: An Open Label, Single Dose, Randomised, Parallel Group Pharmacokinetic Study to Evaluate a Combination Product Containing Naproxen Sodium and Sumatriptan in Adolescent Subjects With Migraine and Healthy Adult Subjects Administered at Three Doses. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00989625 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: This is a pharmacokinetic study (Treximet) Trade Name: Naproxen Sodium and Sumatriptan Study Indication: Migraine Disorders

Evaluation of Naproxen Sodium and Sumatriptan in Adolescent Subjects With Migraine and Healthy Adult Subjects NCT00989625 - Follow-Up - Vital Signs

- 8/8/19 - 1 form, 2 itemgroups, 5 items, 1 language
Itemgroups: Date of visit/assessment , Vital Signs
Study ID: 108504 Clinical Study ID: 108504 Study Title: An Open Label, Single Dose, Randomised, Parallel Group Pharmacokinetic Study to Evaluate a Combination Product Containing Naproxen Sodium and Sumatriptan in Adolescent Subjects With Migraine and Healthy Adult Subjects Administered at Three Doses. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00989625 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: This is a pharmacokinetic study (Treximet) Trade Name: Naproxen Sodium and Sumatriptan Study Indication: Migraine Disorders

Evaluation of Naproxen Sodium and Sumatriptan in Adolescent Subjects With Migraine and Healthy Adult Subjects NCT00989625 - Follow-Up - Vital Signs; Electronically Transferred Lab Data; Study Conclusion; Pregnancy Information

- 8/7/19 - 1 form, 5 itemgroups, 18 items, 1 language
Itemgroups: Date of visit/assessment , Vital Signs, Electronically Transferred Lab Data , Study Conclusion, Pregnancy Information
Study ID: 108504 Clinical Study ID: 108504 Study Title: An Open Label, Single Dose, Randomised, Parallel Group Pharmacokinetic Study to Evaluate a Combination Product Containing Naproxen Sodium and Sumatriptan in Adolescent Subjects With Migraine and Healthy Adult Subjects Administered at Three Doses. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00989625 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: This is a pharmacokinetic study (Treximet) Trade Name: Naproxen Sodium and Sumatriptan Study Indication: Migraine Disorders

Evaluation of Naproxen Sodium and Sumatriptan in Adolescent Subjects With Migraine and Healthy Adult Subjects NCT00989625 - Screen - Demography; Vital Signs

- 8/4/19 - 1 form, 5 itemgroups, 15 items, 1 language
Itemgroups: Inform Screening, Subject number, Date of visit/assessment, Demography, Vital Signs
Study ID: 108504 Clinical Study ID: 108504 Study Title: An Open Label, Single Dose, Randomised, Parallel Group Pharmacokinetic Study to Evaluate a Combination Product Containing Naproxen Sodium and Sumatriptan in Adolescent Subjects With Migraine and Healthy Adult Subjects Administered at Three Doses. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00989625 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: This is a pharmacokinetic study (Treximet) Trade Name: Naproxen Sodium and Sumatriptan Study Indication: Migraine Disorders

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