Arthritis, RheumatoidPhase 3NCT02746380
A Study Comparing LBAL to Humira® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
A Phase 3 study testing LBAL and Humira® in people with Arthritis, Rheumatoid, run by LG Life Sciences at 2 sites in 2 countries.
Trial summary
This is a randomized, double-blind, parallel group, multicenter clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of LBAL compared to Humira® in subjects with active Rheumatoid Arthritis despite Methotrexate therapy. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- LBAL and Humira®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 383 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 13 Apr 2016to 23 Feb 2018
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female patients from 20 years to 75 years of age when signing Informed Consent.
- Diagnosed as having RA (Rheumatoid Arthritis) according to the revised 1987 ACR (American College of Rheumatology) criteria for at least 3 months prior to screening
- Patients who have inadequate response to MTX administered for at least 12 weeks before the beginning of screening period and on a stable dose.
Who cannot join
- patients with active tuberculosis or latent tuberculosis based on current clinical symptoms, chest X-ray test and IFN-γ release assay at screening
- patients with any of the following concomitant diseases and/or history within 24 weeks before the first administration of investigational products in this study; Serious infectious disease, Opportunistic infection, Chronic or recurrent infectious disease
- patients with any seropositive result for hepatitis B or hepatitis C or HIV
- patients who have any of the following diseases; Sepsis, Demyelinating disorders, Lymphoproliferative disease, Infection with prosthetic joint, Autoimmune diseases other than rheumatoid arthritis
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Multi-center (in Korea and Japan), Double-blind, Randomized, Parallel-group Study to Evaluate the Similarity of Efficacy and Safety of LBAL 40mg Subcutaneous Biweekly Injection to Humira® 40mg Subcutaneous Biweekly Injection, as Adjunctive Therapy to Methotrexate (MTX), in Patients With Active Rheumatoid Arthritis Who Had an Inadequate Response to MTX
This is a randomized, double-blind, parallel group, multicenter clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of LBAL compared to Humira® in subjects with active Rheumatoid Arthritis despite Methotrexate therapy.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- LBAL, Humira®
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LBALDrug
Adalimumab
Humira®Drug
Adalimumab
| Study group | Role | What they receive |
|---|---|---|
| LBAL | Experimental | Adalimumab Receives: Drug: LBAL |
| Humira® | Active comparator | Adalimumab Receives: Drug: Humira® |
What is being measured
The primary outcome is the main question the study is designed to answer.
DAS28-ESR
DAS is a combined index to measure the disease activity in patients with Rheumatoid Arthritis (RA).
DAS28-ESR is calculated by assessing the number of swollen and tender joints (among 28 joints) and measuring the ESR.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study start13 Apr 2016
- Primary completion14 Jul 2017
- Study completion23 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies 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
- 383 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mochida Pharmaceutical Company, Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746380
- Sponsor's protocol ID
- LG-ALCL002
- Status last verified
- Mar 2021
- First submitted
- 5 Apr 2016
- Last updated
- 15 Mar 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center (in Korea and Japan), Double-blind, Randomized, Parallel-group Study to Evaluate the Similarity of Efficacy and Safety of LBAL 40mg Subcutaneous Biweekly Injection to Humira® 40mg Subcutaneous Biweekly Injection, as Adjunctive Therapy to Methotrexate (MTX), in Patients With Active Rheumatoid Arthritis Who Had an Inadequate Response to MTX
- ClinicalTrials.gov ID
- NCT02746380
- Acronym / sponsor ID
- LG-ALCL002
- Conditions
- Arthritis, Rheumatoid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 383 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Collaborators
- Mochida Pharmaceutical Company, Ltd.
- Study start
- 13 Apr 2016 (actual)
- Primary completion
- 14 Jul 2017 (actual)
- Study completion
- 23 Feb 2018 (actual)
- First posted
- 21 Apr 2016 (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 a randomized, double-blind, parallel group, multicenter clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of LBAL compared to Humira® in subjects with active Rheumatoid Arthritis despite Methotrexate therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LBAL | Experimental | Drug: LBALAdalimumab |
| Humira® | Active comparator | Drug: Humira®Adalimumab |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or Female patients from 20 years to 75 years of age when signing Informed Consent.
- Diagnosed as having RA (Rheumatoid Arthritis) according to the revised 1987 ACR (American College of Rheumatology) criteria for at least 3 months prior to screening
- Patients who have inadequate response to MTX administered for at least 12 weeks before the beginning of screening period and on a stable dose.
Key exclusion criteria (4 listed)
- patients with active tuberculosis or latent tuberculosis based on current clinical symptoms, chest X-ray test and IFN-γ release assay at screening
- patients with any of the following concomitant diseases and/or history within 24 weeks before the first administration of investigational products in this study; Serious infectious disease, Opportunistic infection, Chronic or recurrent infectious disease
- patients with any seropositive result for hepatitis B or hepatitis C or HIV
- patients who have any of the following diseases; Sepsis, Demyelinating disorders, Lymphoproliferative disease, Infection with prosthetic joint, Autoimmune diseases other than rheumatoid arthritis
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 |
|---|---|---|
| LBALAdalimumab | Drug | LBAL |
| Humira®Adalimumab | Drug | Humira® |
Primary outcome
DAS28-ESR
Time frame: Week 24
DAS is a combined index to measure the disease activity in patients with Rheumatoid Arthritis (RA). DAS28-ESR is calculated by assessing the number of swollen and tender joints (among 28 joints) and measuring the ESR.
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 15 Mar 2021.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LBAL and Humira® in people with Arthritis, Rheumatoid, run by LG Life Sciences at 2 sites in 2 countries.
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 3 inclusion and 4 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 15 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan, 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?
DAS28-ESR (time frame: Week 24). 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 15 Mar 2021; AzTrials last refreshed its copy on 6 Nov 2026.