Efficacy Confirmation Study of CDP870 in Early Rheumatoid Arthritis

Astellas

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: CZP; Drug: methotrexate (MTX); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01451203

JapicCTI-111636 (Other Identifier)

CDP870-275-11-001

Details and patient eligibility

About

The objective of this study is to assess the efficacy of certolizumab pegol (CZP) with methotrexate (MTX) compared with MTX-alone in patients with early-stage rheumatoid arthritis (RA) who are naive to MTX and have with poor prognostic factors, using inhibition of radiographically confirmed joint damage progression over a one-year period as a primary endpoint. Following a year of treatment with CZP plus MTX treatment, CZP will be discontinued, and the subjects will be monitored for one more year (the follow-up period) to investigate the sustainability of efficacy of CZP during the MTX monotherapy for exploratory purposes.

Full description

This study was initiated by Otsuka Pharmaceutical Co., Ltd and transferred to Astellas on 12/04/2012.

Enrollment: 319 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with RA as defined by the ACR/EULAR criteria (2010) who meet all of the following criteria:

  1. Subjects who developed RA within one year after onset of RA.
  2. Subjects who have never received MTX before (MTX naive)
  3. Subjects whose disease activity is moderate or higher (DAS28(ESR) ≥ 3.2）
  4. Subjects must satisfy at least two of the three criteria (Anti-CCP antibody positive, Rheumatoid factor positive, Presence of X-ray erosion） for poor prognostic factors. The anti-CCP antibody positive is essential for every patient.

Exclusion criteria

• Patients who have a diagnosis of any other type of inflammatory arthritis.
• Patients who have a secondary, non-inflammatory type of arthritis.
• Patients who have used with MTX, reflunomide, or any other biologics prior to the start of study drug administration.
• Patients who have NYHA (New York Heart Association) Class III or IV congestive heart failure
• Patients who currently have, or who have a history of, tuberculosis.
• Patients who have a high risk of infection (with a current infectious disease, a chronic infectious disease, a history of serious infectious disease)
• Patients who currently have, or have a history of, malignant tumor
• Female patients who are breastfeeding or pregnant, who are of childbearing potential

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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319 participants in 2 patient groups, including a placebo group

PBO + MTX

Placebo Comparator group

Description:

Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards

Treatment:

Drug: Placebo

Drug: methotrexate (MTX)

CZP + MTX

Experimental group

Description:

Participants who certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards

Treatment:

Drug: methotrexate (MTX)

Drug: CZP