Description:

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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Versions (1) ▾
  1. 3/23/20
Copyright Holder:
GlaxoSmithKline
Uploaded on:

March 23, 2020

DOI:
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License:
Creative Commons BY-NC 4.0
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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

Administrative
Vital Signs - Prior to Infusion
mm[Hg]
mm[Hg]
Subject position
beats/min
°C
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
mL/h
Total Volume of Infusion unit
mL
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?