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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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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

- 3/25/20 - 1 form, 6 itemgroups, 23 items, 1 language
Itemgroups: 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

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 - Early Withdrawal - Tender Joint Count; Swollen Joint Count; Swollen/Tender Joint Count; Electronically Transferred Lab Data

- 3/24/20 - 1 form, 10 itemgroups, 28 items, 1 language
Itemgroups: 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, 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 - 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

Efficacy of ofatumumab in adult patients with active rheumatoid arthritis with inadequate response to methotrexate NCT00611455 - Unscheduled - Electronically Transferred Lab Data; ESR; Neurological Examination; Vital Signs; Liver Event Assessment

- 3/24/20 - 1 form, 5 itemgroups, 20 items, 1 language
Itemgroups: Electronically Transferred Lab Data , ESR, Neurological Examination , Vital Signs , Liver Event Assessment
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 - End of Double Blind - Administrative; Subject Continuation; Phase Conclusion

- 3/24/20 - 1 form, 3 itemgroups, 7 items, 1 language
Itemgroups: Administrative, Subject Continuation, Phase Conclusion
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 - Visit 9 - Vital Signs; ECG; Neurological Examination

- 3/23/20 - 1 form, 3 itemgroups, 11 items, 1 language
Itemgroups: 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 - Visit 4; 6; 9 - Electronically Transferred Lab Data; ESR; PK Blood Sample; Biomarker Samples; Transcriptomic Research Sample Collection Details; Liver Events

- 3/23/20 - 1 form, 6 itemgroups, 27 items, 1 language
Itemgroups: Electronically Transferred Lab Data , ESR, PK Blood Sample - Point in Time Collection, Biomarker Samples, Transcriptomic Research Sample Collection Details , Liver Event Assessment
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 - Visit 4; 5; 7; 8; 9 - Vital Signs; Neurological Examination; Tender Joint Count; Swollen Joint Count; Swollen/Tender Joint Count

- 3/23/20 - 1 form, 11 itemgroups, 26 items, 1 language
Itemgroups: Vital Signs , Neurological Examination, 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
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 - Visit 6 - Vital Signs; Neurological Examination; Tender Joint Count; Swollen Joint Count; Swollen/Tender Joint Count

- 3/23/20 - 1 form, 11 itemgroups, 27 items, 1 language
Itemgroups: Vital Signs , Neurological Examination, 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
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 - Visit 8 - Electronically Transferred Lab Data; ESR; PK Blood Sample; Liver Events

- 3/23/20 - 1 form, 4 itemgroups, 17 items, 1 language
Itemgroups: Electronically Transferred Lab Data , ESR, PK Blood Sample - Point in Time Collection, Liver Event Assessment
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 - Visit 5; 7 - Electronically Transferred Lab Data; ESR; Liver Events

- 3/23/20 - 1 form, 3 itemgroups, 13 items, 1 language
Itemgroups: Electronically Transferred Lab Data , ESR, Liver Event Assessment
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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