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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	29 April 2024
Main ID:	NCT03971253
Date of registration:	30/05/2019
Prospective Registration:	Yes
Primary sponsor:	Astellas Pharma Inc
Public title:	Japan Post-Marketing Surveillance for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis
Scientific title:	Japan Post-Marketing Surveillance - Specified Drug Use-results Survey for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis
Date of first enrolment:	September 2, 2019
Target sample size:	3000
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/ct2/show/NCT03971253
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Japan

Contacts

Name:	Central Contact
Address:
Telephone:
Email:
Affiliation:	Astellas Pharma Inc

Name:	Astellas Pharma Inc.
Address:
Telephone:
Email:	astellas.registration@astellas.com
Affiliation:

Key inclusion & exclusion criteria

Inclusion Criteria:

- All patients with rheumatoid arthritis (RA) treated with peficitinib for the first
time.

Exclusion Criteria:

- Not applicable.

Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis (RA)

Intervention(s)

Drug: Peficitinib

Primary Outcome(s)

European League Against Rheumatism (EULAR) Response Criteria [Time Frame: Up to 52 weeks]

C-reactive protein (CRP) [Time Frame: Up to 52 weeks]

Tender Joint Count (TJC) (28 joints) [Time Frame: Up to 52 weeks]

Safety assessed by frequency of adverse drug reactions (ADRs) [Time Frame: Up to 52 weeks]

Subject's Global Assessment of Arthritis (SGA) (visual analog scale (VAS)) [Time Frame: Up to 52 weeks]

Percentage of participants achieving DAS28-CRP scores for remission [Time Frame: Up to 52 weeks]

Safety assessed by frequency of AEs of special interests [Time Frame: Up to 156 weeks]

Safety assessed by frequency of events leading to death [Time Frame: Up to 156 weeks]

Swollen Joint Count (SJC) (28 joints) [Time Frame: Up to 52 weeks]

Clinical Disease Activity Index (CDAI) score [Time Frame: Up to 52 weeks]

DAS28- erythrocyte sedimentation rate (ESR) score [Time Frame: Up to 52 weeks]

Disease activity score (DAS28) - C-reactive protein (CRP) [Time Frame: Up to 52 weeks]

Erythrocyte sedimentation rate (ESR) [Time Frame: Up to 52 weeks]

Safety assessed by frequency of malignancy [Time Frame: Up to 156 weeks]

Safety assessed by frequency of serious adverse events (SAEs) [Time Frame: Up to 156 weeks]

Percentage of participants achieving DAS28-ESR scores for remission [Time Frame: Up to 52 weeks]

Safety assessed by frequency of adverse events (AEs) [Time Frame: Up to 52 weeks]

Safety assessed by frequency of serious adverse drug reactions (SADRs) [Time Frame: Up to 156 weeks]

Physician's Global Assessment of Arthritis (PGA) (VAS) [Time Frame: Up to 52 weeks]

Simplified Disease Activity Index (SDAI) score [Time Frame: Up to 52 weeks]

Safety assessed by frequency of serious infections [Time Frame: Up to 156 weeks]

Secondary Outcome(s)

Secondary ID(s)

015K-MA-3311

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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