Rheumatoid ArthritisPhase 3NCT01217086
Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in RA Patients(PLANETRA)
A Phase 3 study testing Infliximab in people with Rheumatoid Arthritis, run by Celltrion at 1 site in South Korea.
Trial summary
This is the trial to see how our product is similar to remicade by comparing the results of blood samples when co-administered with methotrexate between 12.5 to 25 mg/week, oral or parenteral dose and folic acid in rheumatoid arthritis patients who are not receiving adequate response to methotrexate alone up to week… 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?
- Infliximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 617 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2010to Jul 2012
- 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
- diagnosed with active rheumatoid arthritis
- at least 3 months of treatment with methotrexate
Who cannot join
- have allergies to infliximab
- serious infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Parallel-group, Phase 3 Study
This is the trial to see how our product is similar to remicade by comparing the results of blood samples when co-administered with methotrexate between 12.5 to 25 mg/week, oral or parenteral dose and folic acid in rheumatoid arthritis patients who are not receiving adequate response to methotrexate alone up to week 30.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Infliximab
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabDrug
Also called remicade
Infliximab 3mg/kg is going to be administered for both arm as a 2-hour infusion per dose.
| Study group | Role | What they receive |
|---|---|---|
| CT-P13 | Active comparator | Not described Receives: Drug: Infliximab |
| Remicade | Active comparator | Not described Receives: Drug: Infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK equivalence to remicade
Measured: PK sampling at week 30
Secondary outcomes (12)
efficacy endpoint
-ACR criteria comparison with Baseline at Weeks 14,30,54
Measured: up to week 54.
efficacy endpoint
- Time to onset of ACR20 response
Measured: Up to week 54.
efficacy endpoint
- Mean decrease in disease activity measured by DAS28 comparison with Baseline at week 30
Measured: Up to week 54.
efficacy endpoint
- Proportion of patients with a good response, defined according to the EULAR response criteria
Measured: Up to week 54.
efficacy endpoint
- ACR20 at weeks 14 and 54
Measured: Up to week 54.
efficacy endpoint
- ACR50 and ACR70 at weeks 14, 30, and 54
Measured: Up to week 54.
efficacy endpoint
- Hybrid ACR response at weeks 14, 30, and 54
Measured: Up to week 54.
efficacy endpoint
- SDAI and CDAI at weeks 14, 30, and 54
Measured: Up to week 54.
efficacy endpoint
- Joint damage progression at week 54
Measured: Up to week 54.
efficacy endpoint
- SF-36 at weeks 14, 30, and 54
Measured: Up to week 54.
efficacy endpoint
- Fatigue
Measured: Up to week 54.
efficacy endpoint
- Number of patients requiring salvage retreatment at weeks 30 and 54
Measured: Up to week 54.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionNov 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 617 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celltrion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dae Hyun Yoo, Principal investigator, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01217086
- Sponsor's protocol ID
- CT-P13 3.1
- Status last verified
- Mar 2013
- First submitted
- 4 Oct 2010
- Last updated
- 12 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Eser A, Reinisch W, Schreiber S, Ahmad T, Boulos S, Mould DR. Increased Induction Infliximab Clearance Predicts Early Antidrug Antibody Detection. J Clin Pharmacol. 2021 Feb;61(2):224-233. doi: 10.1002/jcph.1732. Epub 2020 Sep 9.
PubMed 32905628Yoo DH, Racewicz A, Brzezicki J, Yatsyshyn R, Arteaga ET, Baranauskaite A, Abud-Mendoza C, Navarra S, Kadinov V, Sariego IG, Hong SS, Lee SY, Park W. A phase III randomized study to evaluate the efficacy and safety of CT-P13 compared with reference infliximab in patients with active rheumatoid arthritis: 54-week results from the PLANETRA study. Arthritis Res Ther. 2016 Apr 2;18:82. doi: 10.1186/s13075-016-0981-6.
PubMed 27038608Yoo DH, Hrycaj P, Miranda P, Ramiterre E, Piotrowski M, Shevchuk S, Kovalenko V, Prodanovic N, Abello-Banfi M, Gutierrez-Urena S, Morales-Olazabal L, Tee M, Jimenez R, Zamani O, Lee SJ, Kim H, Park W, Muller-Ladner U. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis. 2013 Oct;72(10):1613-20. doi: 10.1136/annrheumdis-2012-203090. Epub 2013 May 16.
PubMed 23687260
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Parallel-group, Phase 3 Study
- ClinicalTrials.gov ID
- NCT01217086
- Acronym / sponsor ID
- CT-P13 3.1
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 617 participants (actual)
- Lead sponsor
- CelltrionIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 8 Oct 2010 (estimated)
- 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 the trial to see how our product is similar to remicade by comparing the results of blood samples when co-administered with methotrexate between 12.5 to 25 mg/week, oral or parenteral dose and folic acid in rheumatoid arthritis patients who are not receiving adequate response to methotrexate alone up to week 30.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT-P13 | Active comparator | Drug: Infliximab |
| Remicade | Active comparator | Drug: Infliximab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosed with active rheumatoid arthritis
- at least 3 months of treatment with methotrexate
Key exclusion criteria (2 listed)
- have allergies to infliximab
- serious infection
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 |
|---|---|---|
| InfliximabAlso: remicadeInfliximab 3mg/kg is going to be administered for both arm as a 2-hour infusion per dose. | Drug | CT-P13, Remicade |
Primary outcome
PK equivalence to remicade
Time frame: PK sampling at week 30
12 secondary outcomes
efficacy endpoint
Time frame: up to week 54.
efficacy endpoint
Time frame: Up to week 54.
efficacy endpoint
Time frame: Up to week 54.
efficacy endpoint
Time frame: Up to week 54.
efficacy endpoint
Time frame: Up to week 54.
efficacy endpoint
Time frame: Up to week 54.
efficacy endpoint
Time frame: Up to week 54.
efficacy endpoint
Time frame: Up to week 54.
efficacy endpoint
Time frame: Up to week 54.
efficacy endpoint
Time frame: Up to week 54.
efficacy endpoint
Time frame: Up to week 54.
efficacy endpoint
Time frame: Up to week 54.
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 12 Mar 2013.
- Derived from this study: PubMed 32905628Eser A, Reinisch W, Schreiber S, Ahmad T, Boulos S, Mould DR. Increased Induction Infliximab Clearance Predicts Early Antidrug Antibody Detection. J Clin Pharmacol. 2021 Feb;61(2):224-233. doi: 10.1002/jcph.1732. Epub 2020 Sep 9.
- Derived from this study: PubMed 27038608Yoo DH, Racewicz A, Brzezicki J, Yatsyshyn R, Arteaga ET, Baranauskaite A, Abud-Mendoza C, Navarra S, Kadinov V, Sariego IG, Hong SS, Lee SY, Park W. A phase III randomized study to evaluate the efficacy and safety of CT-P13 compared with reference infliximab in patients with active rheumatoid arthritis: 54-week results from the PLANETRA study. Arthritis Res Ther. 2016 Apr 2;18:82. doi: 10.1186/s13075-016-0981-6.
- Derived from this study: PubMed 23687260Yoo DH, Hrycaj P, Miranda P, Ramiterre E, Piotrowski M, Shevchuk S, Kovalenko V, Prodanovic N, Abello-Banfi M, Gutierrez-Urena S, Morales-Olazabal L, Tee M, Jimenez R, Zamani O, Lee SJ, Kim H, Park W, Muller-Ladner U. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis. 2013 Oct;72(10):1613-20. doi: 10.1136/annrheumdis-2012-203090. Epub 2013 May 16.
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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.
Dae Hyun Yoo principal investigator
Hanyang University
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 Infliximab in people with Rheumatoid Arthritis, run by Celltrion at 1 site in South Korea.
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 2 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 12 Mar 2013. 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 South Korea. 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?
PK equivalence to remicade (time frame: PK sampling at week 30). 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 NCT01217086, which also lists 3 linked publications.
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 12 Mar 2013.