An Observational Study to Evaluate Safety and Efficacy of Remsima™ in Patients With Ankylosing Spondylitis

Terminated

Conditions: Ankylosing Spondylitis

Registration Number: NCT02557308

Lead Sponsor: Celltrion

Brief Summary: An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in Patients with Ankylosing Spondylitis

Detailed Description: This is a longitudinal, observational, prospective cohort study to assess the safety and efficacy of RemsimaTM in patients with AS in comparison with patients receiving other TNF blockers. For the RemsimaTM cohort data will be collected for patients who commence treatment with RemsimaTM in accordance with the product label at the time of enrolment. Patients who have been treated with Remicade® prior to enrolment, their dosing schedule will be continued appropriately. This observational study allows drug switching between anti-TNF drugs. If switched to RemsimaTM, data will be collected until the end of study for each patient. If switched to other anti-TNF drugs (infliximab (Remicade®), etanercept, adalimumab and etc.), data will be collected until 1 year from the day of switch or until the end of study for each patient, whichever reaches earlier. For switched patients, their assessment schedule will be re-started from the day of switch. Patients will undergo safety and efficacy assessments in accordance with routine medical practice. The decision to treat with RemsimaTM will be independent of the decision to enroll the patient in this registry.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 329

Inclusion Criteria

Adult patients
Patients with active AS
Patients who meet the following conditions can be enrolled:

i) The RemsimaTM cohort will include all patients who will start RemsimaTM at the time of enrolment in accordance to the approved product label ii) Patients who have started to be treated with an established anti -TNF such as Infliximab (Remicade®), Etanercept, Adalimumab and etc. within 6 months
Female patients of childbearing potential who agree to use of adequate contraception to prevent pregnancy and continuation of contraceptive use for at least 6 months after their final dose of RemsimaTM.
Patients (or legal guardian, if applicable) who are willing to give informed consent for long term follow-up including access to all medical records

Exclusion Criteria

Patients with a history of hypersensitivity to infliximab
Patients with a current or past history of chronic infection
Current diagnosis of TB or severe or chronic infections (e.g. sepsis, abscess or opportunistic infections or invasive fungal infections), or a past diagnosis of TB or severe or chronic infection, without sufficient documentation of complete resolution following treatment.
Recent exposure to persons with active TB, or a positive test result for latent TB (defined as a positive interferon-γ release assay [IGRA] with a negative examination of chest X-ray) at Screening.
Patients with moderate or severe heart failure (NYHA class III/IV).

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Number and Percentage of Patients With the Following Adverse of Events of Special Interest (ESI)	Duration of study participation (up to 5 years)	* Hepatitis B virus reactivation * Congestive heart failure * Opportunistic infections (excluding tuberculosis) * Serious infections including sepsis (excluding opportunistic infections and tuberculosis) * Tuberculosis (TB) * Serum sickness (delayed hypersensitivity reactions) * Haematological reactions * Systemic lupus erythematosus/lupus-like syndrome * Demyelinating disorders * Lymphoma (not hepatosplenic T cell lymphoma) * Hepatobiliary events * Hepatosplenic T cell lymphoma (HSTCL) * Serious infusion reactions during a re-induction regimen following disease flare * Sarcoidosis/sarcoid-like reactions * Leukaemia * Malignancy (excluding lymphoma) * Skin cancer * Pregnancy exposure * Infusion related reaction (IRR)/hypersensitivity/anaphylactic reaction

Secondary Outcome Measures

Name	Time	Method
The Number and Percentage of Patients Achieving BASDAI 50	Month 6 ~ Month 48 (every 6 months ± 6 weeks)	Efficacy was assessed by the evaluation of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). The BASDAI questionnaire consists of 6 component questions about the disease activity. For each question the possible answer from the patient is a whole number from 0 to 10 inclusive where 0 = None and 10 = Very severe. The BASDAI score is generated from the set of 6 questions and calculated using the following formula BASDAI = \[Q1+Q2+Q3+Q4+(\[Q5+Q6\]/2)\]/5. The number and percentage of patients achieving BASDAI 50 will be displayed. BASDAI 50 is defined as a 50% decrease of the baseline BASDAI score. Percentages will be calculated using the number of patients who perform the assessment at each time point.
Descriptive Statistics for BASFI	Day 0 ~ Month 48 (every 6 months ± 6 weeks)	The Bath Ankylosing Spondylitis Functional Index (BASFI) questionnaire consists of 10 component questions measuring functionality. Each item was given a rating by the patient which is a whole number from 0 to 10 inclusive where 0 = Easy and 10 = Impossible. The BASFI score is generated from the mean of the scores for the 10 items. The lowest score is 0 and the highest score is 10, with higher scores indicating a higher degree of functional limitation in patients.
Descriptive Statistics of Physician Global Assessment Score	Day 0 ~ Month 48 (every 6 months ±6 weeks)	Physician and Patient Global Assessment of disease status was measured by Visual Analogue Scale (VAS) (0-100 mm) for EU patients and Numerical Rating Scale (NRS) (0-10) for Korea patients where higher scores indicated poorer status. Descriptive statistics for actual value of Global Assessment Score were summarized by analysis group and every six months including Day 0. For the summary table, each score of Korea patients in NRS was transformed by multiplying 10. Scores are from 0 to 100, with higher scores indicating more disease activity.
Descriptive Statistics of Patient Global Assessment Score	Day 0 ~ Month 48 (every 6 months ±6 weeks)	Physician and Patient Global Assessment of disease status was measured by Visual Analogue Scale (VAS) (0-100 mm) for EU patients and Numerical Rating Scale (NRS) (0-10) for Korea patients where higher scores indicated poorer status. Descriptive statistics for actual value of Global Assessment Score were summarized by analysis group and every six months including Day 0. For the summary table, each score of Korea patients in NRS was transformed by multiplying 10. Scores are from 0 to 100, with higher scores indicating more disease activity.
Descriptive Statistics of Spinal Pain Score	Day 0 ~ Month 48 (every 6 months ±6 weeks)	Patient Assessment of Spinal Pain will be measured by VAS (0-100 mm) for EU patients and NRS (0-10) for Korea patients where higher scores indicates more severe pain. Descriptive statistics for actual value of Spinal Pain Score will be summarized by analysis group and every six months including Day 0. For the summary table, each score of Korea patients in NRS will be transformed by multiplying 10. Scores are from 0 to 100, with higher scores indicating more pain as assessed by the patient.