Open Label Extension for Patients Coming From the Dosing Flexibility Study in Patients With Rheumatoid Arthritis (RA) (Dose Flex II)

UCB

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Certolizumab pegol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00753454

2007-005267-10 (EudraCT Number)

C87084

Details and patient eligibility

About

The purpose of this study is to continue to assess the safety of certolizumab pegol in combination with methotrexate (MTX).

Full description

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.

Enrollment: 168 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must be able to understand the written Informed Consent Form (ICF)
• Patients must have achieved an ACR20 (American College of Rheumatology) response at Week 16 and completed the entire C87077 (NCT00580840) study or patients having been randomized at Week 18 and having met the pre-defined criteria for flare
• Patients must have complied with the protocol requirements during their participation in C87077 (NCT00580840)
• Female patients of childbearing potential must have a negative urine pregnancy test at Entry and must continue to have negative urine pregnancy tests throughout their study participation
• Patients must be willing to comply with protocol

Exclusion criteria

• Patients must not have a diagnosis of any other inflammatory Arthritis
• Patients must not have a secondary, non-inflammatory type of Arthritis that in the investigator's opinion is symptomatic enough to interfere with the evaluation of the study drug on the patient's primary diagnosis of Rheumatoid Arthritis (RA)
• Patients must not have a history of an infected joint prosthesis with that prosthesis still in situ
• Patients who do not meet the Medical History Exclusion criteria, as defined per protocol. Examples of exclusionary criteria (not all-inclusive): pregnancy, chronic infection, active Tuberculosis (TB), high risk of infection, Lymphproliferative Disorder, acute or chronic Viral Hepatitis B or C, known Human Immunodeficiency Virus (HIV), Malignancy or history of Malignancy, history of severe, progressive, and/or uncontrolled Renal, Hepatic, Hematological, Gastrointestinal, Endocrine, Pulmonary, Cardiac, Neurological or Cerebral Disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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168 participants in 1 patient group

CDP870

Experimental group

Description:

Patients having completed the week 34 assessment in C87077 (NCT00580840) or patients having been randomized at Week 18 and having met the pre-defined criteria for flare, will be given the option to enroll in C87084 and receive: 400 mg CZP at Entry, Week 2, and Week 4 followed by 200 mg every two weeks in combination with MTX until the drug is commercially available for the indication of RA in the patient's country or region (or until further notice from UCB).

Treatment:

Drug: Certolizumab pegol