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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  1. 3/25/20
Copyright Holder:
GlaxoSmithKline
Uploaded on:

March 25, 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

Early Withdrawal - ESR; PK Blood Sample; Biomarker Samples; Transcriptomic Research Sample Collection; Liver Events; Investigational Product Discontinuation

ESR
ESR
mm/h
PK Blood Sample - Point in Time Collection
Sample taken?
Biomarker Samples
Has sample been collected?
If sample has not been collected, provide reason
Transcriptomic Research Sample Collection Details
Has a blood sample been collected for transcriptomic research?
Liver Event Assessment
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
Investigational Product Discontinuation
Was the subject withdrawn from future infusions of investigational product?
Select primary reason the investigational product was stopped