753454
Last Update Posted: 2018-08-01
Recruiting has ended
All Genders accepted | 18 Years + |
168 Estimated Participants | Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Open Label Extension for Patients Coming From the Dosing Flexibility Study in Patients With Rheumatoid Arthritis (RA)
The purpose of this study is to continue to assess the safety of certolizumab pegol in combination with methotrexate (MTX).
Patients having completed the week 34 assessment in the C87077 (NCT00580840) study or having met the pre-defined criteria for flare (defined as patients that have randomized at Week 18 and experienced at 2 consecutive visits between Week 18 and Week 34 inclusive an equal to Baseline (W0) or worst swollen and tender joints counts), will be given the option to enroll in C87084 and receive certolizumab pegol [400 mg at Entry, Week 2, and Week 4 followed by 200 mg every two weeks (Q2W)] in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region or until further notice from UCB.
All patients will continue their MTX treatment at the same stable dose as during the C87077 (NCT00580840) study, unless there is a need to reduce the dose for reasons for toxicity.
Eligibility
Relevant conditions:
Rheumatoid Arthritis
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the study if you think are close to fitting criteria.
Inclusion criteria
Exclusion criteria
locations
Data sourced from ClinicalTrials.gov