NCT00233571

CompletedPhase 3

A Long Term Roll-over Study to Investigate the Efficacy and ...

Abbott Source

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Other study identifiers

Sponsor study identifier

DE018

Study Type

interventional

Actual enrollment (reported)

796

Locations

0 countries

Sites

N/A

Timeline

Study Start

June 2000

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

June 2006

Actual (reported)

Study Completion

June 2006

Actual (reported)

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 796 participants
Study completion date: June 2006
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
June 2000
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 13, 2005
Actual (reported)
First Posted
October 6, 2005
Actual (reported)
Primary Completion
June 2006
Actual (reported)
Study Completion
June 2006
Actual (reported)

Last Updated: November 22, 2011
Status Verified: November 2011
Last Update Submitted: November 21, 2011

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

Clinical response indicators
5 years

Secondary Outcomes (1)

Safety parameters
5 years

Study Arms (1)

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

EXPERIMENTAL

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

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

Interventions

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

Also known as: ABT-D2E7, adalimumab, Humira

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

Sponsors & Collaborators

Abbott
Industrylead

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

AdalimumabInjections, Subcutaneous

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized

Study Officials

Hartmut Kupper, MD
Abbott
STUDY DIRECTOR

Enrollment

796 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

October 6, 2005

Study Start

June 2000

Date type not reported

This date has not been verified as actual or estimated.

NCT00235872

Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

Phase 3Completed

NCT00448383

A Study to Assess the Safety and Efficacy of Adalimumab When Added to Inadequate Standard Anti-Rheumatic Therapy in Patients With Active Rheumatoid Arthritis

Phase 3Completed

NCT00647920

Study of Adalimumab Administered as Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate

Phase 3Completed

NCT00234845

Adalimumab in Combination With Methotrexate vs Methotrexate Alone in Early Rheumatoid Arthritis

Phase 3Completed

NCT00603993

Self-injection of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

Phase 3Completed

NCT00870467

A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis

Phase 3Completed

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.

Contact the study team to confirm eligibility.

Antibodies, Monoclonal

Antibodies

Immunoglobulins

Immunoproteins

Blood Proteins

Proteins

Amino Acids, Peptides, and Proteins

Serum Globulins

Globulins

Injections

Drug Administration Routes

Drug Therapy

Therapeutics

Primary Completion

June 2006

Actual (reported)

Study Completion

June 2006

Actual (reported)

Last Updated

November 22, 2011

Record last verified: 2011-11

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00233571
Data provider: ClinicalTrials.gov
Source updated: 2011-11-22
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:40:37 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

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

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record