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 (2) ▾
  1. 4/2/20
  2. 4/2/20
Copyright Holder:
GlaxoSmithKline
Uploaded on:

April 2, 2020

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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

Liver Imaging; Liver Biopsy; Subject Continuation; Electronically Transferred Lab Data

Liver Imaging
What method was used for this imaging test?
Are images technically adequate?
Indicate the liver size
Indicate the liver texture
Grade the diffuse and/or geographic fatty infiltrate of the liver
Ascites present
Are Focal Hepatic Lesions characterisable?
Gallstones or gallbladder lesions?
Biliary ductal lesions?
Portal/Hepatic vein abnormalities?
Liver Biopsy
mm
Final Diagnosis
Liver architecture
Description of Liver Cells or Hepatocytes
Liver Cell or Hepatocyte Inclusions or Vacuoles
Hepatocyte or Liver Cell Nuclear Abnormalities
Liver or Lobular Infiltrates
Portal Tract Inflammation
Bile Ducts
Portal Veins
Liver Infections
Parasites or Ova
Histologic Staining or Additional Studies Obtained
Subject Continuation
Is the subject continuing in the study Follow-up Period?
Electronically Transferred Lab Data
Biochemistry sample taken not done