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Study in Rheumatoid Arthritis for Subjects Who Completed Preceding Study M13-390 With Adalimumab

NCT01752855 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2014-10-29

Study results available
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Summary

A Phase 2b, open-label extension (OLE) study in rheumatoid arthritis (RA) patients designed to collect long-term safety, tolerability, efficacy, and immunogenicity data of the proposed new adalimumab formulation.

Conditions

Interventions

BIOLOGICAL

New formulation adalimumab

New formulation adalimumab 40 mg every other week

Sponsors & Collaborators

  • AbbVie (prior sponsor, Abbott)

    lead INDUSTRY

Principal Investigators

  • Andy Payne, PhD · AbbVie

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • United States
  • Belgium
  • Czechia
  • Germany
  • Puerto Rico
  • Romania
  • Slovakia

Study Locations

More Related Trials

Entities

Diseases

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 NCT01752855 on ClinicalTrials.gov