Moderately to Severely Active Rheumatoid ArthritisPhase 3NCT06738719
A Phase 3 Study to Evaluate Efficacy & Safety of Subcutaneous CT-P13 in Patients With Moderate to Severe Active Rheumatoid Arthritis
A Phase 3 study testing CT-P13 SC Auto-Injector in people with Moderately to Severely Active Rheumatoid Arthritis, run by Celltrion at 1 site in Poland.
Trial summary
This is a Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Evaluate the Efficacy and Safety of Subcutaneous CT-P13 in Patients with Moderately to Severely Active Rheumatoid Arthritis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Moderately to Severely Active Rheumatoid Arthritis
- What is being tested?
- CT-P13 SC Auto-Injector
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 1 sitePoland
- Study dates
- 3 Jan 2025to 13 Apr 2026
- 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
[Main Inclusion Criteria]
- Patient who is male or female aged 18 to 75 years old (both inclusive).
- Patient who has a diagnosis of RA at least 24 weeks prior to the first administration of the study drug (Day 1) and fulfill the 2010 ACR/EULAR classification criteria for RA.
- Patient who has active disease as defined by the presence of 6 or more swollen joints (of 66 assessed), 6 or more tender joints (of 68 assessed), and either a high-sensitivity C-reactive protein (hsCRP) ≥1.0 mg/dL (≥10 mg/L) or an erythrocyte sedimentation rate (ESR) ≥28 mm/hour at Screening.
- Patient who has been receiving the treatment of oral or parenteral dosing with MTX for at least 12 weeks and has been on stable dosing with MTX between 10 to 25 mg/week for at least 4 weeks prior to the first administration of the study drug (Day 1).
- Patient who has adequate renal and hepatic function at Screening
[Main Exclusion Criteria]
- Patient who has previously received investigational or licensed product; biological agents or targeted synthetic disease-modifying antirheumatic drugs (DMARDs) (e.g., tofacitinib, baricitinib) for the treatment of RA and/or a tumor necrosis factor (TNF) α inhibitors for the any purpose.
- Patient who has allergies to any of the excipients of infliximab or any other murine and/or human proteins or patient with a hypersensitivity to immunoglobulin product.
- Patient who has received or has plan to receive any of prohibited medications or treatments as defined in the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Evaluate the Efficacy and Safety of Subcutaneous CT-P13 in Patients With Moderately to Severely Active Rheumatoid Arthritis
This is a Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Evaluate the Efficacy and Safety of Subcutaneous CT-P13 in Patients with Moderately to Severely Active Rheumatoid Arthritis
- Being tested
- CT-P13 SC Auto-Injector, Placebo Auto-Injector
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-P13 SC Auto-InjectorBiological
Subcutaneous(SC) Injection
Placebo Auto-InjectorBiological
Subcutaneous(SC) Injection
| Study group | Role | What they receive |
|---|---|---|
| CT-P13 Auto-Injector | Experimental | CT-P13 SC(Subcutaneous) Auto-Injector Receives: Biological: CT-P13 SC Auto-Injector |
| Placebo Auto-Injector | Placebo comparator | Placebo Auto-Injector Receives: Biological: Placebo Auto-Injector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving clinical response according to the ACR20 criteria at Week 12
To demonstrate superiority of CT P13 SC over Placebo in terms of efficacy as determined by clinical response according to the American College of Rheumatology (ACR) definition of a 20% improvement (ACR20) at Week 12
Measured: Week 0 ~ Week 12
Secondary outcomes (3)
Change from baseline in HAQ-DI at Week 12
Difference in mean change from baseline in HAQ-DI between treatment groups (CT-P13 SC and Placebo)
Measured: Week 0 ~ Week 12
Evaluate Pharmacokinetics of CT-P13 SC
Serum concentration of infliximab
Measured: Up to 52 Weeks
Evaluate Safety of CT-P13 SC
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
- All reported terms of AEs will be coded to system organ class (SOC) and preferred term (PT) according to the Medical Dictionary for Regulatory Activities (MedDRA) and severity grading of AEs will be recorded according to the CTCAE Version 5.0
Measured: Up to 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start3 Jan 2025
- Primary completion25 Jun 2025
- Study completion13 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderately to Severely Active 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
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celltrion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738719
- Sponsor's protocol ID
- CT-P13 3.11
- Status last verified
- Apr 2026
- First submitted
- 10 Dec 2024
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Evaluate the Efficacy and Safety of Subcutaneous CT-P13 in Patients With Moderately to Severely Active Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT06738719
- Acronym / sponsor ID
- CT-P13 3.11
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- CelltrionIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2025 (actual)
- Primary completion
- 25 Jun 2025 (actual)
- Study completion
- 13 Apr 2026 (actual)
- First posted
- 18 Dec 2024 (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.
This is a Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Evaluate the Efficacy and Safety of Subcutaneous CT-P13 in Patients with Moderately to Severely Active Rheumatoid Arthritis
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 Auto-Injector | Experimental | Biological: CT-P13 SC Auto-InjectorCT-P13 SC(Subcutaneous) Auto-Injector |
| Placebo Auto-Injector | Placebo comparator | Biological: Placebo Auto-InjectorPlacebo Auto-Injector |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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-P13 SC Auto-InjectorSubcutaneous(SC) Injection | Biological | CT-P13 Auto-Injector |
| Placebo Auto-InjectorSubcutaneous(SC) Injection | Biological | Placebo Auto-Injector |
Primary outcome
Proportion of patients achieving clinical response according to the ACR20 criteria at Week 12
Time frame: Week 0 ~ Week 12
To demonstrate superiority of CT P13 SC over Placebo in terms of efficacy as determined by clinical response according to the American College of Rheumatology (ACR) definition of a 20% improvement (ACR20) at Week 12
3 secondary outcomes
Change from baseline in HAQ-DI at Week 12
Time frame: Week 0 ~ Week 12
Evaluate Pharmacokinetics of CT-P13 SC
Time frame: Up to 52 Weeks
Evaluate Safety of CT-P13 SC
Time frame: Up to 52 Weeks
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 23 Apr 2026.
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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 SC Auto-Injector in people with Moderately to Severely Active Rheumatoid Arthritis, run by Celltrion at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 23 Apr 2026. 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 Poland. 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. Some participants in this study may receive a placebo. 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?
Proportion of patients achieving clinical response according to the ACR20 criteria at Week 12 (time frame: Week 0 ~ Week 12). 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 23 Apr 2026.