Ankylosing Spondylitis,
Conditions
Interventions
comparative post-
marketing surveillance study to evaluate the safety and efficacy of REMSIMAâ„¢ in patients with Ankylosing Spondylitis,
Rheumatoid Arthritis and Psoriatic Arthritis in Thailand.
Supportive Care
REMSIMAâ„¢ group
non-
observational,
Sponsors
CELLTRION, Inc.
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria will be applied to all indications, if not otherwise specified. 1. Patient is male or female aged 18 to 75 years old, inclusive. 2. For both male and female patient and their partners of childbearing potential either agree to practice total abstinence or use 2 of the following medically acceptable methods of contraception during the course of the study and for 6 months following discontinuation of study drug (excluding women who are not of childbearing potential and men who have been sterilized) 2.1 Barrier contraceptives (male condom, femail condom, or diaphragm with a spermicidal gel) 2.2 Hormonal contraceptives (implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings) 2.3 Intrauterine device Male and female patients and their partners who have been surgically sterilized for less than 6 months prior to the date of informed consent must agree to use 2 medically acceptable methods of contraception or to practice total abstinence. Menopausal females must have experienced their last period more than 12 months prior to the date of informed consent to be classified as not of childbearing. 3. Patient (or legal guardian, if applicable) is infored of the full nature and purpose of the study, including possible risks and side effects, and given ample time and opportunity to read and understand this information, signed and dated the written informed consent before inclusion in the study.
Exclusion criteria
Exclusion criteria: Exclusion criteria will be applied to all indications, if not otherwise specified. 1. Patients with a history of hypersensitivity to murine, chimeric, human or humanized proteins. 2. Patients with a current or past history of chronic infection with Hepatitis B, Hepatitis C or infection with human immunodeficiency virus (HIV) 3. Patient who has an acute infection requiring oral antibiotics within 2 weeks before. Screening, other serious infection within 6 months before screening, or a history of recurrent herpes zoster or other chronic or recurrent infection within 6 weeks before screening 4. Patients with current diagnosis of TB or other severe or chronic infection (such as sepsis, abscess or opportunistic infection, or invasive fungal infection such as histoplasmosis) or a past diagnosis without sufficient documentation of complete resolution following treatment. 5. Patient who has had recent exposure to persons wtih active TB, or who has a positive result to the screening test for latent TB (defined as a positive result for interferon-gamma release assay [IGRA] with a negative examination of chest x-ray). A patient with sufficient documentation of prophylaxis or complete resolution following TB treatment base on local guidelines can be enrolled. During screening, a patient with a positive result for IGRA and a negative examination of chest x-ray who has received at least the first 30 days of country-specific TB therapy and intends to complete the entire course of that therapy can be enrolled. 6. Patients with moderate or severe heart failure (NYHA class III/IV). 7. Patient who have a medical condition including one or more of the following 7.1 History of any malignancy within the previous 5 years except completely excised and cured basal cell carcinoma 7.2 Previous diagnosis or symptoms suggestive of demyelinating disorders 8. Female patient who is current pregnant, breastfeeding, or planing to become pregnant or brestfeed within 6 month of the last dose of study drug. 9.Patient who, in the opinion of his or her general practitioner or the investigator, should not participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ESI: Infection,TB, Hypersensitivity, Malignancy, Drug included liver disease Baseline to end of treatment Incidence and Record form | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events including serious AEs (SAEs), other than classified as ESI Baseline to end of treatment Incidence and Record form,Mycobacterium tuberculosis infection and safety of concomitant medication Baseline to end of treatment Interferon gamma release assay, CRF,Ankylosing Spondylitis Baseilne and week 16 Bath Ankylosing Spondylitis Disease Activity Index ,Physician's global assessment of disease activity Baseilne and week 16 Numerical Rating Scale ,Rheumatoid Arthritis Baseilne and week 16 Disease Activity Score 28,Psoriatic Arthritis Baseilne and week 16 ACR 3 criteria | — |
Countries
Thailand
Contacts
Public ContactProf. Ratanavadee Nanagara
Khonkaen University Hospital
Outcome results
None listed