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Infliximab Biosimilar for Intravenous Drip Infusion 100 mg "Pfizer" Drug Use Investigation (Psoriasis)

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ClinicalTrials.gov Identifier: NCT03885089
Recruitment Status : Not yet recruiting
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
To collect information on the safety and effectiveness of Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" against psoriasis vulgaris, psoriasis arthropathica, pustular psoriasis, or erythrodermic psoriasis under actual status of use.

Condition or disease Intervention/treatment
Psoriasis Vulgaris Psoriasis Arthropathica Pustular Psoriasis Erythrodermic Psoriasis Drug: Infliximab [infliximab biosimilar 3]

Detailed Description:

This study will be conducted with all-case investigation system in patients with psoriasis vulgaris, psoriasis arthropathica, pustular psoriasis, or erythrodermic psoriasis.

This study will be conducted in patients who used this drug after the day of approval of dosage and administration for psoriasis at contracted medical institutions. Patients who used this drug before conclusion of the contract with the medical institution will also be included in this study (retrospective patients will be included).

Therefore, Time Perspective is retrospective and prospective.


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Study Type : Observational
Estimated Enrollment : 1 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: INFLIXIMAB BS FOR INTRAVENOUS DRIP INFUSION 100 MG "PFIZER" DRUG USE INVESTIGATION (PSORIASIS VULGARIS, PSORIASIS ARTHROPATHICA, PUSTULAR PSORIASIS, OR ERYTHRODERMIC PSORIASIS)
Estimated Study Start Date : March 31, 2019
Estimated Primary Completion Date : April 28, 2023
Estimated Study Completion Date : April 28, 2023


Group/Cohort Intervention/treatment
Infliximab [infliximab biosimilar 3]
Patients with Psoriasis Vulgaris, Psoriasis Arthropathica, Pustular Psoriasis, or Erythrodermic Psoriasis treated by Infliximab BS
Drug: Infliximab [infliximab biosimilar 3]
<Psoriasis> The usual dose is 5 mg as Infliximab (Genetical Recombination) [Infliximab Biosimilar 3] for every kg of body weight given as an intravenous infusion. After an initial dose is given, the subsequent doses are given at Weeks 2 and 6, and every 8 weeks thereafter. After a dose at Week 6 is given, the dose may be increased or the dosing interval may be reduced for patients who have an incomplete response or reduced effects. These adjustments should be made in a stepwise manner according to condition of patients. The maximum dose is 10 mg for every kg of body weight at the dosing interval of 8 weeks and 6 mg for every kg of body weight at a reduced dosing interval. The minimum dosing interval is 4 weeks.
Other Name: Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer"




Primary Outcome Measures :
  1. Incidence of adverse drug reactions [ Time Frame: 30 weeks from the day of initial dose ]

Secondary Outcome Measures :
  1. Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response [ Time Frame: Week 30 ]
  2. Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response [ Time Frame: Week 30 ]
  3. Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response [ Time Frame: Week 30 ]
  4. Change from Baseline in Body Surface Area (BSA) [ Time Frame: Baseline, Week 30 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with Psoriasis Vulgaris, Psoriasis Arthropathica, Pustular Psoriasis, or Erythrodermic Psoriasis treated by Infliximab BS
Criteria

Inclusion Criteria:

  • Patients with psoriasis vulgaris, psoriasis arthropathica, pustular psoriasis, or erythrodermic psoriasis who started treatment with this drug
  • Patients who received this drug for the first time at the medical institution after the day of launch of this drug.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885089


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Japan
Pfizer Local Country Office Not yet recruiting
Tokyo, Japan
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03885089     History of Changes
Other Study ID Numbers: B5371009
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Keywords provided by Pfizer:
Infliximab
biosimilar

Additional relevant MeSH terms:
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Psoriasis
Arthritis, Psoriatic
Skin Diseases, Papulosquamous
Skin Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents