CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 402 enrolled
Drug / intervention
Certolizumab Pegolbiological
Likely dose
Certolizumab Pegol 400 mg subcutaneously every 4 weeksAI-extracted
Key inclusion· 3
  • ✓Prior participation in CZP trial C87014 or C87011
  • ✓If female of childbearing potential, adequate contraception since last menses, during study, and for 12 weeks after last dose (or per local regulations), not lactating, negative urine pregnancy test on day of first dose
  • ✓Written informed consent before any study procedures
Key exclusion· 7
  • ✕History of chronic infection, serious or life-threatening infection (including Herpes Zoster) within 6 months prior, or any current symptom indicating infection
  • ✕Current or recent history of severe, progressive and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease
  • ✕Tuberculosis findings at end of previous study
  • ✕Known HIV infection

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

Search/NCT00160693
NCT00160693Phase 3Completed
CompareCT.gov

A Phase III, Multicenter, Open-Label Long-Term Study to Assess the Safety and Tolerability of CDP870 400 mg Subcutaneously Every 4 Weeks, in Subjects With Rheumatoid Arthritis

UCB Pharma·interventional·Posted Sep 12, 2005·Updated Aug 1, 2018

In Brief

A Phase 3 clinical trial evaluating Certolizumab Pegol for Rheumatoid Arthritis. Completed, enrolled 402 participants across 61 sites in 7 countries.

Detailed Summary

The primary purpose of this study is to obtain long-term safety data with CZP in patients with Rheumatoid Arthritis (RA). Additional objectives are to assess the dose and type of Arthritis medication(s) utilized by patients, and to assess the long-term impact of CZP on physical function. Treatment will continue up to approval of a marketing application for this product.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesAustria, Belgium, Czechia, Germany, Ireland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 12, 2005
Enrollment StartMar 1, 2003
Primary CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 7.9 yearsPosted 20.8 years ago

Interventions

Certolizumab Pegolbiological

400 mg of Certolizumab Pegol subcutaneously every 4 Weeks