Arthritis, RheumatoidHUMANNCT03264703
Study in Patients With Moderated to Severe Rheumatoid Arthritis Who Have Failed to Combination Therapy of Conventional Disease-modifying Antirheumatic Drugs (cDMARDs) to cDMARD Plus ANti-TNF Versus cDMARDs in Real World
An observational study of Arthritis, Rheumatoid, run by Eisai Korea Inc. at 15 sites in South Korea.
Trial summary
This study will be conducted to observe the disease activity change of Conventional Disease Modifying Anti-Rheumatic Drugs (cDMARD) plus anti-tumour necrosis factor (anti-TNF) from baseline to 6 months compared with cDMARDs, as measured by the disease activity score with the erythrocyte sedimentation rate (DAS28-ESR). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthritis, Rheumatoid
- How many people
- 212 participants
- Where
- 15 sitesSouth Korea
- Study dates
- 11 Sep 2017to 17 Jul 2019
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Male and female participants diagnosed with rheumatoid arthritis (RA), who have no experience with anti-tumor necrosis factor (anti-TNF) and who have experienced two or more Conventional Disease Modifying Anti-Rheumatic Drugs (cDMARDs) of a stable dose for at least 3 months.
Who may be able to join
- Diagnosed with rheumatoid arthritis within 3 years
- Participants who have no experience with anti-tumor necrosis factor (anti-TNF)
- Participants who have experienced two or more Conventional Disease Modifying Anti-Rheumatic Drugs (cDMARDs) of a stable dose for at least 3 months prior to informed consent
- Participants who change the treatment regimen to one of the following according to the opinion of the investigator:
- One cDMARD plus anti-TNF
- Two or more cDMARDs: Modifications or additions of cDMARDs that have been treated prior to informed consent
Who cannot join
- Participants who may be pregnant or lactating women
- Participants who have contraindication to anti-TNF
- Participants who had participated in this study
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
South Korea15 sites
Eisai Trial Site # 1
Busan
Eisai Trial Site # 2
Busan
Eisai Trial Site # 3
Busan
Eisai Trial Site # 4
Busan
Eisai Trial Site # 1
Daegu
Eisai Trial Site # 2
Daegu
Eisai Trial Site # 1
Ilsan, Gyeonggi-do
Eisai Trial Site # 1
Seoul
Eisai Trial Site # 2
Seoul
Eisai Trial Site # 3
Seoul
Eisai Trial Site # 4
Seoul
Eisai Trial Site # 5
Seoul
Eisai Trial Site # 6
Seoul
Eisai Trial Site # 7
Seoul
Eisai Trial Site # 8
Seoul
About this study
Official title: An Observational Study in Patients With Moderated to Severe Rheumatoid Arthritis Who Have Failed to Combination Therapy of Conventional Disease-modifying Antirheumatic Drugs (cDMARDs) to cDMARD Plus Anti-TNF Versus cDMARDs in Real World ["HUMAN" Study]
This study will be conducted to observe the disease activity change of Conventional Disease Modifying Anti-Rheumatic Drugs (cDMARD) plus anti-tumour necrosis factor (anti-TNF) from baseline to 6 months compared with cDMARDs, as measured by the disease activity score with the erythrocyte sedimentation rate (DAS28-ESR).
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Joint pain, Joint stiffness, Joint redness, Loss of joint function, Swollen joints
- Medical subject headings
- Arthritis, Rheumatoid, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with RA with cDMARD, but no anti-TNF experience | Male and female participants diagnosed with rheumatoid arthritis (RA), who have no experience with anti-tumor necrosis factor (anti-TNF) and who have experienced two or more Conventional Disease Modifying Anti-Rheumatic Drugs (cDMARDs) of a stable dose for at least 3 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the disease activity score 28-erythrocyte sedimentation rate DAS28-ESR at Month 6
DAS28 is a quantitative tool used to measure and monitor disease activity and "the treatment" of rheumatoid arthritis. DAS28 uses a formula that includes the number of tender joints and swollen joints for a maximum of 28 joints. DAS28 is used to assess whether an individual participant has a significant improvement of the disease activity, compared to baseline. A DAS28 score greater than 5.1 implies active disease, a score less than 3.2 implies low disease activity, and a score less than 2.6 implies remission.
Measured: Baseline; Month 6
Secondary outcomes (5)
Change from Baseline in the DAS28-ESR at Month 3
DAS28 is a quantitative tool used to measure and monitor disease activity and "the treatment" of rheumatoid arthritis. DAS28 uses a formula that includes the number of tender joints and swollen joints for a maximum of 28 joints. DAS28 is used to assess whether an individual participant has a significant improvement of the disease activity, compared to baseline. A DAS28 score greater than 5.1 implies active disease, a score less than 3.2 implies low disease activity, and a score less than 2.6 implies remission.
Measured: Baseline; Month 3
Change from Baseline in the DAS28-ESR at Month 12
DAS28 is a quantitative tool used to measure and monitor disease activity and "the treatment" of rheumatoid arthritis. DAS28 uses a formula that includes the number of tender joints and swollen joints for a maximum of 28 joints. DAS28 is used to assess whether an individual participant has a significant improvement of the disease activity, compared to baseline. A DAS28 score greater than 5.1 implies active disease, a score less than 3.2 implies low disease activity, and a score less than 2.6 implies remission.
Measured: Baseline; Month 12
Clinical remission rate measured by DAS28-ESR
Clinical remission is defined as no tender or swollen joints and a normal erythrocyte sedimentation rate. DAS28 will be used to measure disease activity.
Measured: Up to 12 months
Success rates of dose-reduction and discontinuation of steroid(s)
Dose reduction is defined as a reduction by more than 50% compared to baseline.
Measured: Up to 12 months
Scores on the Korean Health Assessment Questionnaire (KHAQ-20), as a measure of quality of life
The KHAQ-20 is a participant-assessed measure of health assessment comprised of 8 indices. Scores for each index range from 0 (no difficulty to do) to 3 (unable to do). The total score is a sum of the 8 index score and ranges from 0 to 24. Higher scores indicate more severe disease.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start11 Sep 2017
- Primary completion17 Jul 2019
- Study completion17 Jul 2019
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Korea Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264703
- Sponsor's protocol ID
- D2E7-M082-601
- Acronym
- HUMAN
- Status last verified
- Mar 2020
- First submitted
- 25 Aug 2017
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study in Patients With Moderated to Severe Rheumatoid Arthritis Who Have Failed to Combination Therapy of Conventional Disease-modifying Antirheumatic Drugs (cDMARDs) to cDMARD Plus Anti-TNF Versus cDMARDs in Real World ["HUMAN" Study]
- ClinicalTrials.gov ID
- NCT03264703
- Acronym / sponsor ID
- HUMAN / D2E7-M082-601
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Joint pain, Joint stiffness, Joint redness, Loss of joint function, Swollen joints
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Eisai Korea Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 17 Jul 2019 (actual)
- Study completion
- 17 Jul 2019 (actual)
- First posted
- 29 Aug 2017 (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 study will be conducted to observe the disease activity change of Conventional Disease Modifying Anti-Rheumatic Drugs (cDMARD) plus anti-tumour necrosis factor (anti-TNF) from baseline to 6 months compared with cDMARDs, as measured by the disease activity score with the erythrocyte sedimentation rate (DAS28-ESR).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with RA with cDMARD, but no anti-TNF experience | – | –Male and female participants diagnosed with rheumatoid arthritis (RA), who have no experience with anti-tumor necrosis factor (anti-TNF) and who have experienced two or more Conventional Disease Modifying Anti-Rheumatic Drugs (cDMARDs) of a stable dose for at least 3 months. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male and female participants diagnosed with rheumatoid arthritis (RA), who have no experience with anti-tumor necrosis factor (anti-TNF) and who have experienced two or more Conventional Disease Modifying Anti-Rheumatic Drugs (cDMARDs) of a stable dose for at least 3 months.
Key inclusion criteria (6 listed)
- Diagnosed with rheumatoid arthritis within 3 years
- Participants who have no experience with anti-tumor necrosis factor (anti-TNF)
- Participants who have experienced two or more Conventional Disease Modifying Anti-Rheumatic Drugs (cDMARDs) of a stable dose for at least 3 months prior to informed consent
- Participants who change the treatment regimen to one of the following according to the opinion of the investigator:
Key exclusion criteria (3 listed)
- Participants who may be pregnant or lactating women
- Participants who have contraindication to anti-TNF
- Participants who had participated in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from Baseline in the disease activity score 28-erythrocyte sedimentation rate DAS28-ESR at Month 6
Time frame: Baseline; Month 6
DAS28 is a quantitative tool used to measure and monitor disease activity and "the treatment" of rheumatoid arthritis. DAS28 uses a formula that includes the number of tender joints and swollen joints for a maximum of 28 joints. DAS28 is used to assess whether an individual participant has a significant improvement of the disease activity, compared to baseline. A DAS28 score greater than 5.1 implies active disease, a score less than 3.2 implies low disease activity, and a score less than 2.6 implies remission.
5 secondary outcomes
Change from Baseline in the DAS28-ESR at Month 3
Time frame: Baseline; Month 3
Change from Baseline in the DAS28-ESR at Month 12
Time frame: Baseline; Month 12
Clinical remission rate measured by DAS28-ESR
Time frame: Up to 12 months
Success rates of dose-reduction and discontinuation of steroid(s)
Time frame: Up to 12 months
Scores on the Korean Health Assessment Questionnaire (KHAQ-20), as a measure of quality of life
Time frame: Up to 12 months
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 16 Dec 2020.
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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.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Rheumatoid, run by Eisai Korea Inc. at 15 sites 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 6 inclusion and 3 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 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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.
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?
Change from Baseline in the disease activity score 28-erythrocyte sedimentation rate DAS28-ESR at Month 6 (time frame: Baseline; Month 6). 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 16 Dec 2020.