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

A Multi-Centre Open Label Continuation Study With Subcutaneous D2E7 (Adalimumab) for Patients With Rheumatoid Arthritis Who Completed a Preceding Clinical Study With D2E7 (Adalimumab)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00233571

Enrollment

796

Registered

2005-10-06

Start date

2000-06-30

Completion date

2006-06-30

Last updated

2011-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief summary

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

Interventions

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Clinical response indicators	5 years

Secondary

Measure	Time frame
Safety parameters	5 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026