Rheumatoid ArthritisPhase 3NCT03707535
To Compare the Efficacy, Pharmacokinetics and Safety Between CT-P13 and China Approved Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis
A Phase 3 study testing CT-P13 and Remicade in people with Rheumatoid Arthritis, run by Celltrion at 1 site in China.
Trial summary
To demonstrate that CT-P13 is equivalent to China-approved Remicade at Week 14, in terms of efficacy as determined by clinical response according to the change from baseline in disease activity. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- CT-P13 and Remicade
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteChina
- Study dates
- 12 Nov 2018to 5 Mar 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has a diagnosis of rheumatoid arthritis
- Has active disease as defined in DAS28 Criteria
Who cannot join
- Has a history of tuberculosis (TB) or a current diagnosis of TB
- Has previously received a biological agent
- Has previously received a tumor necrosis factor alpha (TNF α) inhibitor
- Allergies to any of the excipients of infliximab or hypersensitivity to murine and/or human proteins or immunoglobulin products
- Pregnant or lactating
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled, Double-Blind, Phase 3 Study to Compare the Efficacy, Pharmacokinetics and Safety Between CT-P13 and China Approved Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis
To demonstrate that CT-P13 is equivalent to China-approved Remicade at Week 14, in terms of efficacy as determined by clinical response according to the change from baseline in disease activity.
- Conditions
- Rheumatoid Arthritis
- Being tested
- CT-P13, Remicade
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-P13Biological
3 mg/kg, 2-hour infusion per dose co-administered with methotrexate and folic acid
RemicadeBiological
3 mg/kg, 2-hour infusion per dose co-administered with methotrexate and folic acid
| Study group | Role | What they receive |
|---|---|---|
| CT-P13 | Experimental | Not described Receives: Biological: CT-P13 |
| China-approved Remicade | Active comparator | Not described Receives: Biological: Remicade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy assessment: DAS28 (CRP) at Week 14
Clinical response according to the change from baseline in disease activity as measured by the Disease Activity Score using 28 joint counts (DAS28) (C-reactive protein[CRP])
Measured: Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start12 Nov 2018
- Primary completion16 Mar 2020
- Study completion5 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celltrion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03707535
- Sponsor's protocol ID
- CT-P13 3.6
- Status last verified
- Sep 2021
- First submitted
- 12 Oct 2018
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Double-Blind, Phase 3 Study to Compare the Efficacy, Pharmacokinetics and Safety Between CT-P13 and China Approved Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT03707535
- Acronym / sponsor ID
- CT-P13 3.6
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- CelltrionIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 5 Mar 2021 (actual)
- First posted
- 16 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate that CT-P13 is equivalent to China-approved Remicade at Week 14, in terms of efficacy as determined by clinical response according to the change from baseline in disease activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT-P13 | Experimental | Biological: CT-P13 |
| China-approved Remicade | Active comparator | Biological: Remicade |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Has a diagnosis of rheumatoid arthritis
- Has active disease as defined in DAS28 Criteria
Key exclusion criteria (5 listed)
- Has a history of tuberculosis (TB) or a current diagnosis of TB
- Has previously received a biological agent
- Has previously received a tumor necrosis factor alpha (TNF α) inhibitor
- Allergies to any of the excipients of infliximab or hypersensitivity to murine and/or human proteins or immunoglobulin products
- Pregnant or lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-P133 mg/kg, 2-hour infusion per dose co-administered with methotrexate and folic acid | Biological | CT-P13 |
| Remicade3 mg/kg, 2-hour infusion per dose co-administered with methotrexate and folic acid | Biological | China-approved Remicade |
Primary outcome
Efficacy assessment: DAS28 (CRP) at Week 14
Time frame: Week 14
Clinical response according to the change from baseline in disease activity as measured by the Disease Activity Score using 28 joint counts (DAS28) (C-reactive protein[CRP])
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CT-P13 and Remicade in people with Rheumatoid Arthritis, run by Celltrion at 1 site in China.
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 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: finished, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy assessment: DAS28 (CRP) at Week 14 (time frame: Week 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2021.