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

An observational study of Rheumatoid Arthritis, run by Celltrion.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in Patients with Rheumatoid Arthritis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Rheumatoid Arthritis
How many people: 248 participants
Where: No sites listed yet
Study dates: 17 Dec 2013to 2 Mar 2020
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: The study population will consist of at least 950 male and female patients with Rheumatoid Arthritis

Who may be able to join

Adult patients
Patients with active RA diagnosed according to the revised 1987 ACR or 2010 ACR/EULAR classification criteria

Who cannot join

Patients with a history of hypersensitivity to murine, chimeric, human, or humanized proteins.
Patients with a current or past history of chronic infection
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 Rheumatoid Arthritis

An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in Patients with Rheumatoid Arthritis.

Read the detailed description

This is a longitudinal, observational, prospective cohort study to assess the safety and efficacy of RemsimaTM in patients with RA in comparison with patients receiving non-biologic treatmentsor other anti-TNF drugs. 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 (3 mg/kg of RemsimaTM by IV infusion at weeks 0, 2, 6 (±3 days) and every 8 weeks (±14 days) thereafter). For 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.

Conditions: Rheumatoid Arthritis
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02557295
Study group	Role	What they receive
Remsima™		Patients who have received only Remsima or switched from non-biologic treatment to 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 have received only Remicade or switched from non-biologic treatment to Remsima 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 will be included in this analysis group.
Other Anti-TNF		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 non-biologic treatment to anti-TNF other than Remsima or Remicade * Patients who switched from biologic treatment other than anti-TNF before study enrolment 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 will be included in this analysis group
Biologic Naïve		Patients who received only non-biologic treatment will be 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 reactions associated with shortened infusion duration
- Infusion related reaction (IRR)/hypersensitivity/anaphylactic reaction
Measured: Duration of study participation (up to 5 years)

Secondary outcomes (2)

Descriptive Statistics of Disease Activity Score in 28 Joints (DAS28) (ESR) and DAS28 (CRP)
Disease activity score in 28 joints (DAS28) will be calculated in two ways using the following two equations: DAS28(ESR) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.70 × ln(ESR)) + (0.014 × GH); DAS28(CRP) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.36 × ln(CRP + 1)) + (0.014 × GH) + 0.96
Where:
TJC28 = number of tender joints (0-28): tender joint count (TJC); SJC28 = number of swollen joints (0-28): swollen joint count (SJC); ESR = ESR measurement (mm/h); CRP = CRP measurement (mg/L); GH = Patient Global Assessment of Disease Activity measured on VAS (0 - 100 mm)
Disease activity is indexed as follows, on a 10 point scale, with higher numbers indicating worse disease activity:
Remission: DAS28 < 2.6 Low Disease Activity: 2.6 ≤ DAS28 < 3.2 Moderate Disease Activity: 3.2 ≤ DAS28 ≤ 5.1 High Disease Activity: 5.1 < DAS28
Measured: Day 0 ~ Week 198 (every 6 months ±6 weeks)
Descriptive Statistics for Actual Value of Health Assessment Questionnaire (HAQ) Estimate of Physical Ability
The arthritis-related functional disability will be measured using the disability index of the Health Assessment Questionnaire (HAQ), a validated, self-administered form that assesses functional ability in a number of relevant areas, including the ability to dress, rise from bed, eat, walk, maintain personal hygiene, reach, grip and other activities on a scale ranging from 0 (without any difficulty) to 3 (unable to do). Scores range from 0 to 3, with higher scores indicating worse disability.
There are 8 categories within the Health Assessment Questionnaire. The answer to each question will be scored as follows: Without any difficulty = 0, With some difficulty = 1, With much difficulty = 2, Unable to do = 3.
Divide the summed category scores (using the adjustment score) by the number of categories answered to obtain the HAQ estimate of physical ability.
Measured: Day 0 ~ Week 198 (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.

17 Dec 20132 Mar 2020

First posted23 Sep 2015 (estimated)
Study start17 Dec 2013
Primary completion2 Mar 2020
Study completion2 Mar 2020

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 Rheumatoid ArthritisStudies 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: 248 participants (actual)
Target duration: 5 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT02557295
Sponsor's protocol ID: CT-P13 4.2
Status last verified: Oct 2024
First submitted: 18 Mar 2015
Last updated: 26 Nov 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
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Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Nov 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 Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT02557295
Acronym / sponsor ID: CT-P13 4.2
Conditions: Rheumatoid Arthritis
Study type: Observational
Recruitment status: TerminatedReason stopped: Terminated
Enrolment: 248 participants (actual)
Lead sponsor: CelltrionIndustry (pharma, biotech, devices)
Study start: 17 Dec 2013 (actual)
Primary completion: 2 Mar 2020 (actual)
Study completion: 2 Mar 2020 (actual)
First posted: 23 Sep 2015 (estimated)
Results: Posted 5 Feb 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 Rheumatoid Arthritis.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 5 Years
Number of arms: 9

Arm	Type	Receives
Remsima™	–	–Patients who have received only Remsima or switched from non-biologic treatment to 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 have received only Remicade or switched from non-biologic treatment to Remsima 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 will be included in this analysis group.
Other Anti-TNF	–	–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 non-biologic treatment to anti-TNF other than Remsima or Remicade * Patients who switched from biologic treatment other than anti-TNF before study enrolment 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 will be included in this analysis group
Biologic Naïve	–	–Patients who received only non-biologic treatment will be 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: The study population will consist of at least 950 male and female patients with Rheumatoid Arthritis

Key inclusion criteria (2 listed)

Adult patients
Patients with active RA diagnosed according to the revised 1987 ACR or 2010 ACR/EULAR classification criteria

Key exclusion criteria (3 listed)

Patients with a history of hypersensitivity to murine, chimeric, human, or humanized proteins.
Patients with a current or past history of chronic infection
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 reactions associated with shortened infusion duration * Infusion related reaction (IRR)/hypersensitivity/anaphylactic reaction

2 secondary outcomes

Descriptive Statistics of Disease Activity Score in 28 Joints (DAS28) (ESR) and DAS28 (CRP)
Time frame: Day 0 ~ Week 198 (every 6 months ±6 weeks)
Descriptive Statistics for Actual Value of Health Assessment Questionnaire (HAQ) Estimate of Physical Ability
Time frame: Day 0 ~ Week 198 (every 6 months ±6 weeks)

Results and safety

Results posted to the registry on 5 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Remsima	111	0
Switch to Remsima	8	0
Switch to Remsima II	15	0
Remicade	3	0
Switch to Remicade	0	0
Switch to Remicade II	0	0
Other Anti-TNF	81	0
Switch to Other Anti-TNF	7	0
Biologic Naïve	23	0

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). Count of participants. Unit: Participants

Measure	Remsima n = 111	Switch to Remsima I n = 8	Switch to Remsima II n = 15	Remicade n = 3	Other Anti-TNF n = 81	Biologic Naïve n = 23
TEAE of Serious infections including sepsis (excluding opportunistic infections and tuberculosis)	5	1	1	0	1	1
TEAE of tuberculosis	7	0	0	0	5	0
TEAE of Haematological reactions	5	0	0	0	5	0
TEAE of Systemic lupus erythematosus/lupus-like syndrom	1	0	0	0	0	0
TEAE of Hepatobiliary events	6	1	1	1	5	1
TEAE of Malignancies (excluding lymphoma)	1	0	0	0	1	1
TEAE of Infusion reactions associated with shortened infusion duration	4	1	1	0	0	0
TEAE of Infusion related reaction/hypersensitivity/ anaphylactic reaction	15	1	3	0	2	0

Population analysed: The analysis period for patients with one switching after enrollment were defined as the whole period beginning on the date of first switching, for patients with two or more switching after enrollment, the period between first and second switching was used. All patients data were analyzed; however, there were 0 patients recruited in the "Switch to Remicade I" and "Switch to Remicade II" groups.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Duration of study participation (up to 5 years). Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Remsima	16 of 111 (14.4%)	56 of 111 (50.5%)	0 of 111
Switch to Remsima I	2 of 8 (25%)	6 of 8 (75%)	0 of 8
Switch to Remsima II	4 of 15 (26.7%)	7 of 15 (46.7%)	0 of 15
Remicade	2 of 3 (66.7%)	3 of 3 (100%)	0 of 3
Switch to Remicade I	0 of 0	0 of 0	0
Switch to Remicade II	0 of 0	0 of 0	0
Other Anti-TNF	11 of 81 (13.6%)	39 of 81 (48.1%)	0 of 81
Switch to Other Anti-TNF	0 of 7 (0%)	3 of 7 (42.9%)	0 of 7
Biologic Naïve	2 of 23 (8.7%)	13 of 23 (56.5%)	0 of 23

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 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.

Related trials for Rheumatoid Arthritis

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
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Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
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Not yet recruitingPhase 1
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Active, not recruitingPhase 2
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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 Rheumatoid Arthritis, 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 2 inclusion and 3 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 26 Nov 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 5 Feb 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 NCT02557295, 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 26 Nov 2024.