None listed
Conditions
Interventions
Group 1 Type of group
CT-P13 (5 mg / kg) administered as an infusion of 2 hours per dose.
Group name:Group 2 Type of group
Remicade (5 mg / kg) administered as an infusion of 2 hours per dose.
Sponsors
Celltrion, Inc.,
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: • The patient is male or female between 18 and 75 years of age, inclusive. • The patient was diagnosed with active AS according to the New York classification criteria modified in 1984 [van der Linden et al 1984] at least 3 months before the Selection. • Patients have active disease as defined by the Bath Index for Ankylosing Spondylitis Disease Activity Index (BASDAI) with a score of> 4 (range 0 to 10) by at least 3 months before the Selection. • Patients have a visual analog scale score for pain in the spine of> 4 (range O to 10). • Both men and women and their partners with reproductive potential should agree to use 2 medically approved contraceptive methods (eg, barrier contraceptives [male condom, female condom, OR diaphragm with spermicidal gel, hormonal contraceptives [implants, injections, combination of oral contraceptives, transdermal patches, or contraceptive rings], and intrauterine devices) during the course of the study and for 6 months after discontinuation of the study treatments (excluding women who do not have reproductive potential and men who have been sterilized) . • Male and female patients and their partners who have been surgically sterilized for less than 6 months before entering the study must agree to use 2 medically accepted contraceptive methods according to the inclusion criteria Error! The origin of the reference is not found. • Menopausal women must have submitted their last period more than 12 months before entering the study to be classified as without reproductive potential. • Patients have adequate renal and hepatic function in the Selection • Patients are allowed to receive both oral glucocorticoids equivalent to <10 mg of daily prednisolone and nonsteroidal anti-inflammatory drugs, if they have received a stable dose for at least 4 weeks before Selection. • Patients have the ability to fully understand the nature and intention of the study, including possible risks and side effects; to cooperate with the Investigator, to understand verbal and written instructions, and to comply with the requirements of the entire study. • The patient (or legal representative, if applicable) is informed of the nature and purpose of the study, including possible risks and side effects, and is given enough time and opportunity to read and understand this information, sign and date the informed consent before its inclusion in the study.
Exclusion criteria
Exclusion criteria: • Patients who have previously been given a biological agent for the treatment of AS. • Patients who have total spinal ankylosis, as defined by syndesmophytes present in the lateral views of spine radiographs at all intervertebral levels, from T6 to S1, inclusive. • Patients who have allergies to any of the infliximab excipients or any other murine and human protein. • Patients who have a current or past history of chronic infection with hepatitis B, hepatitis C or infection with the human immunodeficiency virus -1 or -2 or who have a positive result for these infections in the National Team. • Patients who have a current diagnosis of tuberculosis (TE) or other severe or chronic infection (such as sepsis, abscesses or opportunistic infections, or an invasive fungal infection such as histoplasmosis) or a past diagnosis without sufficient documentation of complete recovery after treatment. • Patients who have recently been exposed to people with active TE, or who have a positive screening test for latent TE defined as a positive result of the interferon-release assay and with a negative evaluation of the chest x-ray, and who have not received at least the first 30 days of therapy for country-specific TE and do not intend to complete all that therapy. • Patients who have had another serious infection that has not been excluded in the 6 months prior to the Selection or who have a history of chronic infections. • Patients who have a current or past history of drug or alcohol abuse. • Patients who have a medical history • Patients who have participated in a study with an investigational drug within 6 months prior to the Selection or who are currently receiving treatment with any other investigational medication or device. • Female patients who are currently pregnant or breastfeeding, or who are planning to become pregnant or breastfeed within 6 months after the last dose of CT-P 13 or the Remicade reference product. • Patients who have received a live or live attenuated vaccine within 8 weeks prior to the Selection or who are scheduled to receive a live or live attenuated vaccine. Dead vaccines are accepted during the study. • Patients who, in the opinion of their general practitioner or the Researcher, should not participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:AUCt: Area under the concentration-time curve during the dosing interval, in a stable state between Week 22 and Week 30. Cmax.ss Maximum serum concentration observed in a stable state between Week 22 and Week 30. Measure:Statistical comparison of AUCt and Cmax, ss observed among patients treated with CT-P 13 or the Remicade reference product in a stable state between Week 22 and Week 30. Timepoints:Week 22 and Week 30. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Seran realizadas evaluaciones fisicas con particular atencion a reacciones infecciosas o relacionadas con la infusion en cada visita excepto en la visita de 24 horas Measure:Proportion of patients reaching a clinical response according to the ASAS20 criteria Timepoints:During the study ; Outcome name:Seran realizadas evaluaciones fisicas con particular atencion a reacciones infecciosas o relacionadas con la infusion en cada visita excepto en la visita de 24 horas Measure:Proportion of patients reaching a clinical response according to ASAS40 criteria Timepoints:During the study ; Outcome name:Bath indices for Ankylosing Spondylitis as well as thoracic expansion [Sieper et al 2009] are measurements of the signs and symptoms of the disease (pain, stiffness in the spine), mobility in the spine, and physical function. Measure:BASDAI in Weeks 14, 30 and 54 compared to the Baseline Timepoints:Weeks 14, 30 and 54 ; Outcome name:Bath indices for Ankylosing Spondylitis as well as thoracic expansion [Sieper et al 2009] are measurements of the signs and symptoms of the disease (pain, stiffness in the spine), mobility in the spine, and physical function. Measure:BASFI in Weeks 14, 30 and 54 compared to the Baseline Timepoints:Weeks 14, 30 and 54 ; Outcome name:Bath indices for Ankylosing Spondylitis as well as thoracic expansion [Sieper et al 2009] are measurements of the signs and symptoms of the disease (pain, stiffness in the spine), mobility in the spine, and physical function. Measure:BASMI in Weeks 14, 30 and 54 compared to the Baseline Timepoints:Weeks 14, 30 and 54 | — |
Contacts
Public ContactLuis Miguel Melendez
PPD Peru S.A.C.
Outcome results
None listed