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 Identifier: NCT00611455 Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ofatumumab, Placebo Study Indication: Arthritis, Rheumatoid

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  1. 3/23/20
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March 23, 2020

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Efficacy of ofatumumab in adult patients with active rheumatoid arthritis with inadequate response to methotrexate NCT00611455

Visit 3 - Vital Signs; Electronically Transferred Lab Data; PK Blood Sample; Investigational Product IV Dosing; Liver Event Assessment

Vital Signs - Prior to Infusion
Subject position
Location of temperature
Electronically Transferred Lab Data
Haematology sample taken - Not Done
Biochemistry sample taken - Not Done
Urinalysis sample taken - Not Done
PK Blood Sample - Before Infusion
Sample taken before infusion?
PK Blood Sample - End of Infusion
Sample taken at end of infusion?
PK Type Code
Investigational Product - IV Dosing
Was dose interrupted?
Primary reason for interruption
Total Volume of Infusion unit
Was the total volume of infusion administered?
Primary reason for stoppage?
Liver Event Assessment
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?