New arthritis drug shows promise in major trial
NCT ID NCT06738719
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested an injectable drug called CT-P13 in 192 adults with moderate-to-severe rheumatoid arthritis. The goal was to see if it reduces joint pain and swelling better than a placebo. Participants received either the drug or a dummy shot, and researchers measured improvement after 12 weeks using standard arthritis scores.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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192 people
The number who actually took part.
- Started
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Jan 2025
- Finished
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Apr 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
\[Main Inclusion Criteria\] 1. Patient who is male or female aged 18 to 75 years old (both inclusive). 2. 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. 3. 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. 4. 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). 5. Patient who has adequate renal and hepatic function at Screening \[Main Exclusion Criteria\] 1. 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. 2. 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. 3. Patient who has received or has plan to receive any of prohibited medications or treatments as defined in the protocol.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Klinika Reuma Park Sp. z.o.o
Warsaw, 02-665, Poland