Clinical trial NCT01680159: A Clinical Study of Increased Dose of TA-650 in Patients With Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plaque Psoriasis
Psoriatic Arthritis
Pustular Psoriasis (Excluding a Localized)
Psoriatic Erythroderma
Keywords: Infliximab
REMICADE
TA-650
psoriasis
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2012-09-07
Enrollment: 51
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of TA-650 at increased dose of 10 mg/kg every 8 weeks in patients with psoriasis in whom effect of the treatment was confirmed after the treatment with Remicade® at 5 mg/kg every 8 weeks but decreased thereafter.

Detailed description: * Patients with plaque psoriasis or psoriatic arthritis:

  1. 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.
  2. 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.

Eligibility criteria: Inclusion Criteria:

* Patients who have already been diagnosed as having plaque psoriasis, psoriatic arthritis, pustular psoriasis (excluding a localized), or psoriatic erythroderma.
* 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.

Exclusion Criteria:

* Patients who have guttate psoriasis.
* Patients who have drug-induced psoriasis
* Patients who have previously used any other biological products than infliximab.
* 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 a concomitant diagnosis, or a history within 6 months prior to provisional enrollment, of opportunistic infections
* Female patients who are pregnant, breast-feeding, or possibly pregnant.

Primary outcomes:
measure: Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score
timeFrame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period
Secondary outcomes:
measure: Psoriasis Area and Severity Index (PASI) Score
timeFrame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period
measure: Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis)
timeFrame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period
measure: Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis)
timeFrame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period
measure: Assessment of Severity (Only for Patients With Pustular Psoriasis)
timeFrame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period
Other outcomes:
Locations:
city: Chubu
country: Japan
facility: Investigational site
city: Chugoku
country: Japan
facility: Investigational site
city: Hokkaido
country: Japan
facility: Investigational site
city: Kanto
country: Japan
facility: Investigational site
city: Kinki
country: Japan
facility: Investigational site
city: Kyushu
country: Japan
facility: Investigational site
city: Tohoku
country: Japan
facility: Investigational site
Study officials:
affiliation: Social Insurance Central General Hospital
name: Hideshi Torii, MD
role: STUDY_DIRECTOR
affiliation: Mitsubihsi Tanabe Pharma Corporation
name: Kazuoki Kondo, MD
role: STUDY_DIRECTOR
affiliation: The Jikei University School of Medicine
name: Hidemi Nakagawa, MD
role: STUDY_CHAIR
References: