NCT00233571

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
796

participants targeted

Target at P75+ for phase_3 rheumatoid-arthritis

Timeline
Completed

Started Jun 2000

Longer than P75 for phase_3 rheumatoid-arthritis

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2000

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 6, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

November 22, 2011

Status Verified

November 1, 2011

Enrollment Period

6 years

First QC Date

September 13, 2005

Last Update Submit

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)

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:

  • 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.

Sponsors & Collaborators

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, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsInjectionsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Hartmut Kupper, MD

    Abbott

    STUDY DIRECTOR

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 1, 2000

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

November 22, 2011

Record last verified: 2011-11