NCT01451203 - Efficacy Confirmation Study of CDP870 in Early Rheumatoid Arthritis | Crick

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

319

Conditions

Rheumatoid Arthritis

Interventions

PlaceboDRUG

Subcutaneous (SC)

CZPDRUG

SC

methotrexate (MTX)DRUG

oral

Eligibility

Sex: ALLMin age: 20 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Locations (8)

Unnamed facility

Chubu Region, Japan

Unnamed facility

Chugoku Region, Japan

Unnamed facility

Hokkaido Region, Japan

Unnamed facility

Kanto Region, Japan

Unnamed facility

Outcomes

Primary Outcomes

Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52

Radiographs/X-rays of hands and feet (posteroanterior views of both hands and dorsoplantar views of both feet) were independently assessed by two radiographic readers. The degree of joint damage was graded by assessing bone erosion in 44 joints and joint space narrowing (JSN) in 42 joints. The bone erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (complete collapse of bone). The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The mTSS ranges from 0 (normal) to 448 (worst).

Time frame: Baseline and Week 52

Secondary Outcomes

Change From Baseline in mTSS at Week 24

Radiographs/X-rays of hands and feet (posteroanterior views of both hands and dorsoplantar views of both feet) were independently assessed by two radiographic readers. The degree of joint damage was graded by assessing bone erosion in 44 joints and joint space narrowing (JSN) in 42 joints. The bone erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (complete collapse of bone). The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The mTSS ranges from 0 (normal) to 448 (worst).

Time frame: Baseline and Week 24

Clinical Remission Rate: Percentage of Participants Meeting the Disease Activity Score-28 Joint Count (DAS28) Erythrocyte Sedimentation Rate (ESR) (DAS28[ESR]) Remission Criteria at Weeks 24 and 52