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Repeat Dose Subcutaneous Rhumatoid Arthritis Efficacy Study

NCT01101555 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2022-11-16

No results posted yet for this study

Summary

This study is a randomised, single-blind, placebo-controlled, repeat dose study of otelixizumab administered subcutaneously in rheumatoid arthritis patients. One cohort will receive a single dose of adalimumab (HUMIRA, Abbott) as rescue medication to assess additional concomitant safety and tolerability issues.

Conditions

  • Arthritis, Rheumatoid

Interventions

DRUG

subcutanious administration

drug will be administered subcutaneously in varying amounts over a verying time period according to details stated in the 'arms' section

OTHER

Placebo

Placebo will be given to one member of each cohort.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-12
Primary Completion
2011-09-16
Completion
2012-11-29

Countries

  • Russia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01101555 on ClinicalTrials.gov