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A Long Term Roll-over Study to Investigate the Efficacy and Safety of Adalimumab Given Long-term to Patients With Rheumatoid Arthritis

NCT ID: NCT00233571

Last Updated: 2011-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

796 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-06-30

Study Completion Date

2006-06-30

Brief Summary

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The purpose of the study is to assess the long-term safety and clinical efficacy of adalimumab in patients with rheumatoid arthritis

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Adalimumab 40mg subcutaneous (SC) every other week (EOW)

Adalimumab 40mg subcutaneous (SC) every other week (EOW)

Group Type EXPERIMENTAL

Adalimumab 40 mg subcutaneous (SC) every other week (EOW)

Intervention Type BIOLOGICAL

Interventions

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Adalimumab 40 mg subcutaneous (SC) every other week (EOW)

Intervention Type BIOLOGICAL

Other Intervention Names

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ABT-D2E7 adalimumab Humira

Eligibility Criteria

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Inclusion Criteria

* Completion of a previous D2E7 study
* Subject is in good health (Investigator discretion) with a recent stable medical history

Exclusion Criteria

* Former enrollment in this trial (DE018)
* Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study
* Female subject who is pregnant or breast feeding or considering becoming pregnant.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hartmut Kupper, MD

Role: STUDY_DIRECTOR

Abbott

Other Identifiers

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DE018

Identifier Type: -

Identifier Source: org_study_id