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. 4/2/20
Copyright Holder:
GlaxoSmithKline
Uploaded on:

April 2, 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

Vital Signs prior to Infusion; Liver Events; Investigational Product (Liver); Pharmacokinetics (Liver); Alcohol Intake; Medical Conditions (Liver)

Vital Signs - Prior to Infusion
kg
mm[Hg]
mm[Hg]
Subject position
beats/min
°C
Location of temperature
Liver Events
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Is the subject age 55 or older?
If female, is the subject pregnant?
Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as liver ultrasound, computerised tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
If any diagnostic imaging tests of the liver or hepatobiliary system were performed, were the results normal?
Were any liver biopsies performed?
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
Did the subject fast or undergo significant dietary change in the past week?
Investigational Product (Liver)
Start Date Investigational Product - During treatment period
Stop Date Investigational Product - During treatment period
Start Date Investigational Product - After treatment period
Stop Date Investigational Product - After treatment period
Pharmacokinetics (Liver)
Was a pharmacokinetic blood sample obtained?
Alcohol intake
Does the subject consume alcohol?
Medical Conditions (Liver)
Medical Condition
Condition Status
Drug related liver disease conditions
Drug related liver disease status
Other Liver disease conditions
Other Liver disease conditions - Status
Other medical conditions
Other medical condition
Other medical condition