Ankylosing SpondylitisNCT02557308
An Observational Study to Evaluate Safety and Efficacy of Remsima™ in Patients With Ankylosing Spondylitis
An observational study of Ankylosing Spondylitis, run by Celltrion.
Trial summary
An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in Patients with Ankylosing Spondylitis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankylosing Spondylitis
- How many people
- 329 participants
- Where
- No sites listed yet
- Study dates
- 26 May 2015to 28 Feb 2021
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 1000 male or female patients with confirmed diagnosis of AS.
Who may be able to join
- Adult patients
- Patients with active AS
- Patients who meet the following conditions can be enrolled:
- 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
Who cannot join
- 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).
About this study
Official title: An Observational, Prospective, Cohort Study to Evaluate Safety and Efficacy of Remsima™ in Patients With Ankylosing Spondylitis
An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in Patients with Ankylosing Spondylitis
Read the 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.
- Conditions
- Ankylosing Spondylitis
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Remsima™ | Patients who have received only Remsima were included in this analysis group | |
| Switch to Remsima I | Patients who switched from Remicade to Remsima were included in this analysis group. | |
| Switch to Remsima II | Patients who switched to Remsima from biologic treatment other than Remicade were included in this analysis group | |
| Remicade | Patients who switched from Remsima to Remicade were included in this analysis group. | |
| Switch to Remicade I | Patients who switched from Remsima to Remicade were included in this analysis group. | |
| Switch to Remicade II | Patients who switched to Remicade from biologic treatment other than Remsima were included in this analysis group. | |
| Other anti-TNF drugs | Following patients were included in other anti-TNF group. * Patients who have received only anti-TNF other than Remsima or Remicade * Patients who switched from biologic treatment other than anti-TNF before study enrollment to anti-TNF other than Remsima or Remicade | |
| Switch to Other Anti-TNF | Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade were included in this analysis group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number and Percentage of Patients With the Following Adverse of Events of Special Interest (ESI)
- 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
Measured: Duration of study participation (up to 5 years)
Secondary outcomes (5)
The Number and Percentage of Patients Achieving BASDAI 50
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.
Measured: Month 6 ~ Month 48 (every 6 months ± 6 weeks)
Descriptive Statistics for BASFI
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.
Measured: Day 0 ~ Month 48 (every 6 months ± 6 weeks)
Descriptive Statistics of Physician Global Assessment Score
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.
Measured: Day 0 ~ Month 48 (every 6 months ±6 weeks)
Descriptive Statistics of Patient Global Assessment Score
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.
Measured: Day 0 ~ Month 48 (every 6 months ±6 weeks)
Descriptive Statistics of Spinal Pain Score
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.
Measured: Day 0 ~ Month 48 (every 6 months ±6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study start26 May 2015
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Why it stopped: Terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 329 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Celltrion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Klara Sirova, Principal investigator, Revmatologie MUDr. Klara Sirova s.r.o. Chelčického 616/12 , 702 00, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02557308
- Sponsor's protocol ID
- CT-P13 4.4
- Status last verified
- Oct 2024
- First submitted
- 15 May 2015
- Last updated
- 9 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cheon JH, Nah S, Kang HW, Lim YJ, Lee SH, Lee SJ, Kim SH, Jung NH, Park JE, Lee YJ, Jeon DB, Lee YM, Kim JM, Park SH. Infliximab Biosimilar CT-P13 Observational Studies for Rheumatoid Arthritis, Inflammatory Bowel Diseases, and Ankylosing Spondylitis: Pooled Analysis of Long-Term Safety and Effectiveness. Adv Ther. 2021 Aug;38(8):4366-4387. doi: 10.1007/s12325-021-01834-3. Epub 2021 Jul 12.
PubMed 34250583
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Prospective, Cohort Study to Evaluate Safety and Efficacy of Remsima™ in Patients With Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT02557308
- Acronym / sponsor ID
- CT-P13 4.4
- Conditions
- Ankylosing Spondylitis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated
- Enrolment
- 329 participants (actual)
- Lead sponsor
- CelltrionIndustry (pharma, biotech, devices)
- Study start
- 26 May 2015 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 23 Sep 2015 (estimated)
- Results
- Posted 9 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Remsima™ | – | –Patients who have received only Remsima were included in this analysis group |
| Switch to Remsima I | – | –Patients who switched from Remicade to Remsima were included in this analysis group. |
| Switch to Remsima II | – | –Patients who switched to Remsima from biologic treatment other than Remicade were included in this analysis group |
| Remicade | – | –Patients who switched from Remsima to Remicade were included in this analysis group. |
| Switch to Remicade I | – | –Patients who switched from Remsima to Remicade were included in this analysis group. |
| Switch to Remicade II | – | –Patients who switched to Remicade from biologic treatment other than Remsima were included in this analysis group. |
| Other anti-TNF drugs | – | –Following patients were included in other anti-TNF group. * Patients who have received only anti-TNF other than Remsima or Remicade * Patients who switched from biologic treatment other than anti-TNF before study enrollment to anti-TNF other than Remsima or Remicade |
| Switch to Other Anti-TNF | – | –Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade were included in this analysis group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 1000 male or female patients with confirmed diagnosis of AS.
Key inclusion criteria (6 listed)
- Adult patients
- Patients with active AS
- Patients who meet the following conditions can be enrolled:
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Number and Percentage of Patients With the Following Adverse of Events of Special Interest (ESI)
Time frame: 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
5 secondary outcomes
The Number and Percentage of Patients Achieving BASDAI 50
Time frame: Month 6 ~ Month 48 (every 6 months ± 6 weeks)
Descriptive Statistics for BASFI
Time frame: Day 0 ~ Month 48 (every 6 months ± 6 weeks)
Descriptive Statistics of Physician Global Assessment Score
Time frame: Day 0 ~ Month 48 (every 6 months ±6 weeks)
Descriptive Statistics of Patient Global Assessment Score
Time frame: Day 0 ~ Month 48 (every 6 months ±6 weeks)
Descriptive Statistics of Spinal Pain Score
Time frame: Day 0 ~ Month 48 (every 6 months ±6 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34250583Cheon JH, Nah S, Kang HW, Lim YJ, Lee SH, Lee SJ, Kim SH, Jung NH, Park JE, Lee YJ, Jeon DB, Lee YM, Kim JM, Park SH. Infliximab Biosimilar CT-P13 Observational Studies for Rheumatoid Arthritis, Inflammatory Bowel Diseases, and Ankylosing Spondylitis: Pooled Analysis of Long-Term Safety and Effectiveness. Adv Ther. 2021 Aug;38(8):4366-4387. doi: 10.1007/s12325-021-01834-3. Epub 2021 Jul 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klara Sirova principal investigator
Revmatologie MUDr. Klara Sirova s.r.o. Chelčického 616/12 , 702 00, Czech Republic
Questions about this trial
What is this clinical trial studying?
An observational study of Ankylosing Spondylitis, run by Celltrion.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number and Percentage of Patients With the Following Adverse of Events of Special Interest (ESI) (time frame: Duration of study participation (up to 5 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02557308, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.