Completed

A Clinical Study of Increased Dose of TA-650 in Patients With Psoriasis

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What is being tested

TA-650

Drug
Who is being recruted

Arthritis+10

+ Bone Diseases

+ Joint Diseases

From 16 to 75 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: July 2012
See protocol details

Summary

Principal SponsorTanabe Pharma Corporation
Last updated: January 8, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2012

Actual date on which the first participant was enrolled.

Patients with plaque psoriasis or psoriatic arthritis: Screening Period: TA-650 at 5 mg per kg body weight is administered on the day of TA-650 administration at the start (week 0) and week 8 (if efficacy is not judged as decreased or maintained at week 8 of the screening period) , respectively, by intravenous infusion slowly over at least 2 hours. Increased Dose Period: If efficacy is judged as decreased in the screening period, TA-650 at 10 mg per kg body weight is administered on the day of TA-650 administration at the start (week 0) and at every 8 weeks up to week 32 in the increased dose period , respectively, as one dose by intravenous infusion slowly over at least 2 hours. Patients with pustular psoriasis or psoriatic erythroderma: TA-650 at 10 mg per kg body weight is administered on the day of TA-650 administration at the start (week 0) and at every 8 weeks up to week 32, respectively, as one dose by intravenous infusion slowly over at least 2 hours.

NCT01680159
Principal SponsorTanabe Pharma Corporation
Last updated: January 8, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

51 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 16 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisBone DiseasesJoint DiseasesMusculoskeletal DiseasesSkin DiseasesSpinal DiseasesSpondylitisSkin and Connective Tissue DiseasesSkin Diseases, PapulosquamousSpondylarthritisSpondylarthropathiesPsoriasisArthritis, Psoriatic

Criteria

2 inclusion criteria required to participate
Patients in whom effect of the treatment was confirmed for a certain period after the start of administration of Remicade at 5 mg/kg at every 8 weeks but decreased thereafter
Patients who have already been diagnosed as having plaque psoriasis, psoriatic arthritis, pustular psoriasis (excluding a localized), or psoriatic erythroderma
6 exclusion criteria prevent from participating
Female patients who are pregnant, breast-feeding, or possibly pregnant
Patients who have a concomitant diagnosis, or a history within 6 months prior to provisional enrollment, of opportunistic infections
Patients who have a concomitant diagnosis, or a history within 6 months prior to provisional enrollment, of serious infections that need hospitalization
Patients who have drug-induced psoriasis
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Investigational site

Chugoku, JapanOpen Investigational site in Google Maps

Investigational site

Chūbu, Japan

Investigational site

Hokkaido, Japan

Investigational site

Kanto, Japan
Completed7 Study Centers