CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 846 enrolled
Drug / intervention
Adalimumabbiological
Likely dose
Adalimumab 40 mg subcutaneous injection every other week or monthlyAI-extracted
Key inclusion· 3
  • ✓Participant must have been enrolled in a prior D2E7 (adalimumab) study
  • ✓Age 18 years or older
  • ✓In good health per investigator discretion with recent stable medical history
Key exclusion· 3
  • ✕Pregnant or breast-feeding, or considering becoming pregnant
  • ✕Ongoing chronic or active infection
  • ✕Considered unsuitable candidate for the study by investigator

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00195650
NCT00195650Phase 3Completed
CompareCT.gov

A Multi-Center Continuation Study of the Human Anti-TNF Antibody D2E7 Administered as a Subcutaneous Injection in Patients With Rheumatoid Arthritis

Abbott·interventional·Posted Sep 20, 2005·Updated Aug 31, 2012

In Brief

A Phase 3 clinical trial evaluating Adalimumab for Rheumatoid Arthritis. Completed, enrolled 846 participants across 92 sites in 2 countries.

Detailed Summary

The purpose of the study was to assess the long-term safety and clinical efficacy following repeated administration of adalimumab in patients with rheumatoid arthritis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 20, 2005
Enrollment StartJul 1, 2000
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 10.8 yearsPosted 20.8 years ago

Interventions

Adalimumabbiological

Subcutaneous injection of 40 mg adalimumab every other week (eow) or monthly for up to 520 weeks (10 years)