Continuation of certolizumab pegol with Or Without MTX in RA patients achieving sustained remissioN and low disease activity

JRCT ID: jRCTs071190001

Registered date:02/04/2019

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: Rheumatoid arthritis
• Date of first enrollment: 29/08/2019
• Target sample size: 150
• Study type: Interventional

Intervention(s)

Patients retaining LDA with the combination of CZP and MTX are randomized to two groups consisting of patients who continue MTX at the same doses or discontinue MTX. The effects of both groups are compared 1 year after starting study.

Control group
combination therapy with subcutaneous CZP (200 mg in every 2 weeks or 400 mg in every 4 weeks) and oral MTX (at the same dose before starting the protocol treatment) given for 52 weeks of the protocol treatment, or until the time of discontinuation.

Intervention group
monotherapy with CZP (200 mg in every 2 weeks or 400 mg in every 4 weeks) given for 52 weeks of the protocol treatment, or until the time of discontinuation.

The discontinuation criteria for the study are as follows:
1) When subjects requested to discontinue the treatment
2) When the principal investigator or subinvestigator considered that the therapy should be discontinued due to adverse (drug) events
3) When a subject turned out not to fulfil the inclusion criteria or meets the exclusion criteria after starting the study
4) When RA relapses, defined as SDAI over 11, were observed at two consecutive visits
5) When the principal investigator or subinvestigator considered continuation of the study is inappropriate for reasons other than above

Outcome(s)

• Primary Outcome: Percentage of patients with SDAI less than 11 at 12, 24, and 52 weeks after starting the study

Secondary Outcome

SDAI remission rate at 52 weeks after starting the study
DAS28-ESR remission rate at 52 weeks after starting the study
Duration of protocol therapy
Change from baseline in the mTSS at 52 weeks after starting the study

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients aged over 16 years (at the time of informed consent)
2) Patients diagnosed with rheumatoid arthritis (RA) under the 1987 American College of Rheumatology (ACR) or 2010 ACR/European League Against Rheumatism (EULAR) criteria
3) Patients who have been receiving combination therapy with MTX ( over 6 mg/week) and CZP for 24 weeks before enrollment of the study
4) Patients who showed SDAI less than 11 at any visit for over 3 months before enrollment without taking any steroids
5) Patients who provided written informed consent

• Exclude criteria: Patients judged by the investigator to be unsuitable for participants in the study

Related Information

• Primary Sponsor: Miyazaki Yusuke
• Secondary Sponsor: Tanaka Yoshiya

Source(s) of Monetary Support

UCB S.A.
Astellas Pharma Inc.