Open-label, Extension Study of CDP870 in Patients With Rheumatoid Arthritis

Otsuka

Status and phase

Completed

Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Drug: Certolizumab Pegol

Study type

Interventional

Funder types

Industry

Identifiers

NCT01197066

101-KOA-0802i

Details and patient eligibility

About

This is a phase Ⅲ multicenter, open-label, follow-up study, to assess the safety and efficacy of certolizumab pegol (CZP) as additional medication to methotrexate (MTX), in patients with active rheumatoid arthritis (RA) who participated in Study (Protocol) # 101-KOA-0801i.

Enrollment

110 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Failed to achieve an ACR20 response at Week 12 in the Study 101-KOA-0801i or completed the entire Study 101-KOA-0801i through Week 24
Have a clear chest X-ray at the Entry visit
Negative urine pregnancy test at the Entry
Continue treatment on methotrexate

Exclusion criteria

Any other inflammatory arthritis (e.g., psoriatic arthritis, ankylosing spondylitis or reactive arthritis)
Secondary, non-inflammatory type of arthritis (eg, osteoarthritis, fibromyalgia)
At study entry taking any of the prohibited medications as detailed in the Study (Protocol) # 101-KOA-0801i
NYHA (New York Heart Association) Class III or IV congestive heart failure
Current or history of tuberculosis
History of chronic infection, recent serious or life-threatening infection or any current sign or symptom that may indicate an infection (e.g., fever, cough)
History of a lymphoproliferative disorder including lymphoma or signs and symptoms suggesting lymphoproliferative disease
High risk of infection
Female breast feeding, pregnant or plan to become pregnant during the trial or for 12 weeks following the last dose of study drug