Rheumatoid ArthritisPhase 4NCT03505008
Evaluation of the Optimal MTX Dose as an Add-on Therapy to Adalimumab for RA Patients in Japan, South Korea and Taiwan
A Phase 4 study testing Methotrexate and Adalimumab in people with Rheumatoid Arthritis, run by Keio University at 24 sites in 3 countries.
Trial summary
This study will be conducted in Japan, South Korea and Taiwan to evaluate the optimal dosage of methotrexate (MTX) as an add-on therapy to adalimumab (ADA) in participants with rheumatoid arthritis (RA) who have not achieved remission by MTX monotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Methotrexate and Adalimumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 24 sitesin 3 countries
- Study dates
- 18 Apr 2018to 11 May 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥18 years (≥20 years in Taiwan) at the time of informed consent
- Patients who meet the 1987 revised ACR criteria or 2010 ACR/EULAR criteria
- Patients who have RA within 2 years from initial diagnosis to informed consent
- Patients who were previously untreated with MTX, JAK inhibitor, or bDMARDs
- Patients who have disease activity of SDAI >11 at screening
- Patients who are no need for concomitant use of DMARDs other than hydroxychloroquine (only in South Korea and Taiwan) and study drugs during the study as judged by principal investigator/sub-investigator at screening
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- Patients who are no need for concomitant use of corticoid steroid equivalent to >10 mg/day prednisolone during the study as judged by principal investigator/sub-investigator at screening.
- Female of child-bearing potential who can use appropriate contraceptive during the study, female in whom time from menopause to informed consent is ≥1 year, or female of no child-bearing potential through sterilization (bilateral tubal ligation, bilateral ovariectomy or hysterectomy, etc.)
- Virile male who can use appropriate contraceptive during the study
- Patients who can adequately understand this study procedures, and voluntarily consent in writing to take part in this study (consent of a legally-acceptable representative is also required for patients aged <20 years in Japan and aged <19 years in South Korea)
Who cannot join
- Patients who currently have a malignant tumor, except for non-melanoma forms of skin cancer limited within epidermis, and uterine cervix cancer limited within epidermis
- Patients who have serious infections such as sepsis
- Patients who have active tuberculosis
- Patients who have a history or current complication of demyelinating disease such as multiple sclerosis
- Patients who have congestive heart failure
- Pregnant female, or female who intend to conceive during the study period
Show all 13Show fewer
- Patients who have bone marrow depression and whom investigator considered ineligible
- Patients who have chronic liver disease and whom investigator considered ineligible, and who is positive for HBs antigen
- Patients who have nephropathy and whom investigator considered ineligible
- Lactating female
- Patients who have pleural effusion or ascites
- Patients with a known hypersensitivity to MTX or ADA
- Patients otherwise whom principal investigator/sub-investigator considered medically ineligible to participate in the study
Trial locations and contacts
24 sites in 3 countries.
24 sites in 3 countries
Japan12 sites
Fujita Health University Hospital
Aichi
Chiba University Hospital
Chiba
Hiroshima University Hospital
Hiroshima
Kawasaki Municipal Hospital
Kanagawa
Tokai University Hospital
Kanagawa
Tohoku University Hospital
Miyagi
Nagoya University Hospital
Nagoya
Seirei Hamamatsu General Hospital
Shizuoka
Keio University Hospital
Tokyo
National Hospital Organization Tokyo Medical Center
Tokyo
Nippon Medical School Hospital
Tokyo
Toho University Ohashi Medical Center
Tokyo
South Korea6 sites
Chungbuk National University Hospital
Cheongju-si
Chungnam National University Hospital
Daejeon
Gachon University Gil Medical Center
Incheon
Seoul National University Bundang Hospital
Seongnam
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
Taiwan6 sites
Chang Gung Medical Foundation, Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
China Medical University Hospital
Taichung
National Cheng Kung University Hospital
Tainan
National Taiwan University Hospital
Taipei
Chang Gung Medical Foundation, Linkou Chang Gung Memorial Hospital
Taoyuan
About this study
Official title: MIRACLE (Methotrexate Inadequate Response Patient With Rheumatoid Arthritis Treated by Adalimumab in Combination With Low-dose Methotrexate) Study
This study will be conducted in Japan, South Korea and Taiwan to evaluate the optimal dosage of methotrexate (MTX) as an add-on therapy to adalimumab (ADA) in participants with rheumatoid arthritis (RA) who have not achieved remission by MTX monotherapy.
Read the detailed description
The erythrocyte MTX-polyglutamates (MTX-PG) concentration will be measured to evaluate its relationship to the efficacy and safety of MTX therapy.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Methotrexate, Adalimumab
- Keywords
- Methotrexate, Adalimumab, Autoimmune Disease, Connective Tissue Diseases, Rheumatic Disease, Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid, Autoimmune Diseases, Connective Tissue Diseases, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Also called MTX
Route of Administration: Oral
AdalimumabDrug
Also called ADA
Route of Administration: Subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| MTX-Monotherapy Group | Experimental | Participants will receive Methotrexate (MTX) at a starting dose of 6 to 8 mg/week, which will be promptly escalated to the maximum tolerated dose (MTD) of ≤25 mg/week up to Week 12, and maintained until Week 24. If the dosage of MTX is maintained ≥ 10 mg/week and simple disease activity index (SDAI) remission is achieved at Week 24, the MTX therapy will continue until Week 48. Receives: Drug: Methotrexate |
| ADA/MTX-Maximum Tolerated Dose Group | Experimental | Participants will receive Methotrexate (MTX) at a starting dose of 6 to 8 mg/week, which will be promptly escalated to the MTD of ≤25 mg/week up to Week 12, and maintained until Week 24. If the dosage of MTX is maintained ≥ 10 mg/week and SDAI remission is not achieved at Week 24, Adalimumab (ADA) 40 mg will be administered subcutaneously every other week in addition to the MTX therapy until Week 48. Receives: Drug: Methotrexate; Drug: Adalimumab |
| ADA/MTX-Reduced Dose Group | Experimental | Participants will receive Methotrexate (MTX) at a starting dose of 6 to 8 mg/week, which will be promptly escalated to the MTD of ≤25 mg/week up to Week 12, and maintained until Week 24. If the dosage of MTX is maintained ≥ 10 mg/week and SDAI remission is not achieved at Week 24, Adalimumab (ADA) 40 mg will be administered subcutaneously every other week in addition to low-dose MTX (6 to 8 mg/week) treatment until Week 48. Receives: Drug: Methotrexate; Drug: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simple Disease Activity Index (SDAI) Remission Rate at Week 48 in mFAS
SDAI is a validated combined index of rheumatoid arthritis disease activity, defined as the sum of Swollen Joint Count (0-28), Tender Joint Count (0-28), Patient's Global Assessment of Disease Activity (measured on a visual analogue scale with a range of 0 [none] to 10 [most severe]), Physician's Global Assessment of Disease Activity (measured on a visual analogue scale with a range of 0 [none] to 10 [most severe]), and C-reactive protein (mg/dL).
Higher scores represent higher disease activity. SDAI ≤ 3.3 indicates disease remission, > 3.4 to 11 = low disease activity, > 11 to 26 = moderate disease activity, and > 26 = high disease activity.
Measured: Week 48
Secondary outcomes (6)
Simple Disease Activity Index (SDAI) Remission Rate at Week 48 in PPS
SDAI is a validated combined index of rheumatoid arthritis disease activity, defined as the sum of Swollen Joint Count (0-28), Tender Joint Count (0-28), Patient's Global Assessment of Disease Activity (measured on a visual analogue scale with a range of 0 [none] to 10 [most severe]), Physician's Global Assessment of Disease Activity (measured on a visual analogue scale with a range of 0 [none] to 10 [most severe]), and C-reactive protein (mg/dL).
Higher scores represent higher disease activity. SDAI ≤ 3.3 indicates disease remission, > 3.4 to 11 = low disease activity, > 11 to 26 = moderate disease activity, and > 26 = high disease activity.
Measured: Week 48
American College of Rheumatology (ACR) 20 Response Rate at Week 48
ACR 20 response is defined as a subject meeting all of the following 3 criteria based on the evaluation results of tender joint count, swollen joint count, VAS (physician- and patient reported), HAQ, and CRP. Also, the proportion of ACR 20 response will be referred to as ACR 20 response rate.
- ≥20% improvement in the tender joint count (of the total 68 joints) compared to Week 0 of treatment
- ≥20% improvement in the swollen joint count (of the total 66 joints) compared to Week 0 of treatment
- ≥20% improvement in ≥3 of 5 parameters (physician- and patient-reported disease activities, patient-reported pain score, HAQ, and CRP) compared to Week 0 of treatment
Measured: Week 48
American College of Rheumatology (ACR) 50 Response Rate at Week 48
ACR 50 response is defined as a subject meeting all of the following 3 criteria based on the evaluation results of tender joint count, swollen joint count, VAS (physician- and patient reported), HAQ, and CRP. Also, the proportion of ACR 50 response will be referred to as ACR 50 response rate.
- ≥50% improvement in the tender joint count (of the total 68 joints) compared to Week 0 of treatment
- ≥50% improvement in the swollen joint count (of the total 66 joints) compared to Week 0 of treatment
- ≥50% improvement in ≥3 of 5 parameters (physician- and patient-reported disease activities, patient-reported pain score, HAQ, and CRP) compared to Week 0 of treatment
Measured: Week 48
American College of Rheumatology (ACR) 70 Response Rate at Week 48
ACR 70 response is defined as a subject meeting all of the following 3 criteria based on the evaluation results of tender joint count, swollen joint count, VAS (physician- and patient reported), HAQ, and CRP. Also, the proportion of ACR 70 response will be referred to as ACR 70 response rate.
- ≥70% improvement in the tender joint count (of the total 68 joints) compared to Week 0 of treatment
- ≥70% improvement in the swollen joint count (of the total 66 joints) compared to Week 0 of treatment
- ≥70% improvement in ≥3 of 5 parameters (physician- and patient-reported disease activities, patient-reported pain score, HAQ, and CRP) compared to Week 0 of treatment
Measured: Week 48
Health Assessment Questionnaire - Disability Index ≤0.5 at Week 48
HAQ-DI is a patient-reported questionnaire, consists of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week as: without any difficulty (0); with some difficulty (1); with much difficulty (2); unable to do (3). Scores on each task were summed and averaged to provide an overall score from 0 to 3, where 0=no disability and 3=very severe, high-dependency disability. Normal physical function is defined by HAQ-DI score of < 0.5.
Measured: Week 48
Change in Modified Total Sharp Score ≤ 0.5 at Week 48
Bone erosions will be evaluated for each region from a scale of 0 (no damage) to 5 (complete collapse of the joint). The score will be 0 to 5 for each hand joint, and 0 to 10 for each foot joint. The maximum total erosion score of both hands will be 160 points, and that of both feet will be 120 points.
Joint space narrowing will be evaluated for each region from a scale of 0 (no damage) to 4 (ankylosis or luxation). The maximum total joint space narrowing score of both hands will be 120 points, and that of both feet will be 48 points.
Erosion scores and joint space narrowing scores were added to obtain the mTSS (range from 0 to 448).
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start18 Apr 2018
- Primary completion11 May 2021
- Study completion11 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keio University
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai Co., Ltd.
- Responsible party
- Principal investigator, Yuko Kaneko, Keio University
- Investigators
- Yuko Kaneko, MD, PhD, Principal investigator, Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505008
- Sponsor's protocol ID
- D2E7-C000-401
- Status last verified
- Mar 2025
- First submitted
- 16 Apr 2018
- Last updated
- 6 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tamai H, Ikeda K, Miyamoto T, Taguchi H, Kuo CF, Shin K, Hirata S, Okano Y, Sato S, Yasuoka H, Kuwana M, Ishii T, Kameda H, Kojima T, Nishi Y, Mori M, Miyagishi H, Toshima G, Sato Y, Tsai WC, Takeuchi T, Kaneko Y; MIRACLE Study Group. Association of methotrexate polyglutamates concentration with methotrexate efficacy and safety in patients with rheumatoid arthritis treated with predefined dose: results from the MIRACLE trial. Ann Rheum Dis. 2025 Jan;84(1):41-48. doi: 10.1136/ard-2024-226350. Epub 2025 Jan 2.
PubMed 39874232Tamai H, Ikeda K, Miyamoto T, Taguchi H, Kuo CF, Shin K, Hirata S, Okano Y, Sato S, Yasuoka H, Kuwana M, Ishii T, Kameda H, Kojima T, Taninaga T, Mori M, Miyagishi H, Sato Y, Tsai WC, Takeuchi T, Kaneko Y; MIRACLE study collaborators. Reduced versus maximum tolerated methotrexate dose concomitant with adalimumab in patients with rheumatoid arthritis (MIRACLE): a randomised, open-label, non-inferiority trial. Lancet Rheumatol. 2023 Apr;5(4):e215-e224. doi: 10.1016/S2665-9913(23)00070-X.
PubMed 38251524
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIRACLE (Methotrexate Inadequate Response Patient With Rheumatoid Arthritis Treated by Adalimumab in Combination With Low-dose Methotrexate) Study
- ClinicalTrials.gov ID
- NCT03505008
- Acronym / sponsor ID
- D2E7-C000-401
- Conditions
- Rheumatoid Arthritis
- Keywords
- Methotrexate, Adalimumab, Autoimmune Disease, Connective Tissue Diseases, Rheumatic Disease, Rheumatoid Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Keio UniversityUniversity, hospital or other
- Collaborators
- Eisai Co., Ltd.
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 11 May 2021 (actual)
- Study completion
- 11 May 2021 (actual)
- First posted
- 20 Apr 2018 (actual)
- Results
- Posted 6 Mar 2025
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 in Japan, South Korea and Taiwan to evaluate the optimal dosage of methotrexate (MTX) as an add-on therapy to adalimumab (ADA) in participants with rheumatoid arthritis (RA) who have not achieved remission by MTX monotherapy.
Detailed description
The erythrocyte MTX-polyglutamates (MTX-PG) concentration will be measured to evaluate its relationship to the efficacy and safety of MTX therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MTX-Monotherapy Group | Experimental | Drug: MethotrexateParticipants will receive Methotrexate (MTX) at a starting dose of 6 to 8 mg/week, which will be promptly escalated to the maximum tolerated dose (MTD) of ≤25 mg/week up to Week 12, and maintained until Week 24. If the dosage of MTX is maintained ≥ 10 mg/week and simple disease activity index (SDAI) remission is achieved at Week 24, the MTX therapy will continue until Week 48. |
| ADA/MTX-Maximum Tolerated Dose Group | Experimental | Drug: Methotrexate, Drug: AdalimumabParticipants will receive Methotrexate (MTX) at a starting dose of 6 to 8 mg/week, which will be promptly escalated to the MTD of ≤25 mg/week up to Week 12, and maintained until Week 24. If the dosage of MTX is maintained ≥ 10 mg/week and SDAI remission is not achieved at Week 24, Adalimumab (ADA) 40 mg will be administered subcutaneously every other week in addition to the MTX therapy until Week 48. |
| ADA/MTX-Reduced Dose Group | Experimental | Drug: Methotrexate, Drug: AdalimumabParticipants will receive Methotrexate (MTX) at a starting dose of 6 to 8 mg/week, which will be promptly escalated to the MTD of ≤25 mg/week up to Week 12, and maintained until Week 24. If the dosage of MTX is maintained ≥ 10 mg/week and SDAI remission is not achieved at Week 24, Adalimumab (ADA) 40 mg will be administered subcutaneously every other week in addition to low-dose MTX (6 to 8 mg/week) treatment until Week 48. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients aged ≥18 years (≥20 years in Taiwan) at the time of informed consent
- Patients who meet the 1987 revised ACR criteria or 2010 ACR/EULAR criteria
- Patients who have RA within 2 years from initial diagnosis to informed consent
- Patients who were previously untreated with MTX, JAK inhibitor, or bDMARDs
- Patients who have disease activity of SDAI >11 at screening
Key exclusion criteria (13 listed)
- Patients who currently have a malignant tumor, except for non-melanoma forms of skin cancer limited within epidermis, and uterine cervix cancer limited within epidermis
- Patients who have serious infections such as sepsis
- Patients who have active tuberculosis
- Patients who have a history or current complication of demyelinating disease such as multiple sclerosis
- Patients who have congestive heart failure
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 |
|---|---|---|
| MethotrexateAlso: MTXRoute of Administration: Oral | Drug | ADA/MTX-Maximum Tolerated Dose Group, ADA/MTX-Reduced Dose Group, MTX-Monotherapy Group |
| AdalimumabAlso: ADARoute of Administration: Subcutaneous | Drug | ADA/MTX-Maximum Tolerated Dose Group, ADA/MTX-Reduced Dose Group |
Primary outcome
Simple Disease Activity Index (SDAI) Remission Rate at Week 48 in mFAS
Time frame: Week 48
SDAI is a validated combined index of rheumatoid arthritis disease activity, defined as the sum of Swollen Joint Count (0-28), Tender Joint Count (0-28), Patient's Global Assessment of Disease Activity (measured on a visual analogue scale with a range of 0 [none] to 10 [most severe]), Physician's Global Assessment of Disease Activity (measured on a visual analogue scale with a range of 0 [none] to 10 [most severe]), and C-reactive protein (mg/dL). Higher scores represent higher disease activity. SDAI ≤ 3.3 indicates disease remission, > 3.4 to 11 = low disease activity, > 11 to 26 = moderate disease activity, and > 26 = high disease activity.
6 secondary outcomes
Simple Disease Activity Index (SDAI) Remission Rate at Week 48 in PPS
Time frame: Week 48
American College of Rheumatology (ACR) 20 Response Rate at Week 48
Time frame: Week 48
American College of Rheumatology (ACR) 50 Response Rate at Week 48
Time frame: Week 48
American College of Rheumatology (ACR) 70 Response Rate at Week 48
Time frame: Week 48
Health Assessment Questionnaire - Disability Index ≤0.5 at Week 48
Time frame: Week 48
Change in Modified Total Sharp Score ≤ 0.5 at Week 48
Time frame: Week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39874232Tamai H, Ikeda K, Miyamoto T, Taguchi H, Kuo CF, Shin K, Hirata S, Okano Y, Sato S, Yasuoka H, Kuwana M, Ishii T, Kameda H, Kojima T, Nishi Y, Mori M, Miyagishi H, Toshima G, Sato Y, Tsai WC, Takeuchi T, Kaneko Y; MIRACLE Study Group. Association of methotrexate polyglutamates concentration with methotrexate efficacy and safety in patients with rheumatoid arthritis treated with predefined dose: results from the MIRACLE trial. Ann Rheum Dis. 2025 Jan;84(1):41-48. doi: 10.1136/ard-2024-226350. Epub 2025 Jan 2.
- Derived from this study: PubMed 38251524Tamai H, Ikeda K, Miyamoto T, Taguchi H, Kuo CF, Shin K, Hirata S, Okano Y, Sato S, Yasuoka H, Kuwana M, Ishii T, Kameda H, Kojima T, Taninaga T, Mori M, Miyagishi H, Sato Y, Tsai WC, Takeuchi T, Kaneko Y; MIRACLE study collaborators. Reduced versus maximum tolerated methotrexate dose concomitant with adalimumab in patients with rheumatoid arthritis (MIRACLE): a randomised, open-label, non-inferiority trial. Lancet Rheumatol. 2023 Apr;5(4):e215-e224. doi: 10.1016/S2665-9913(23)00070-X.
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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.
Yuko Kaneko, MD, PhD principal investigator
Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine
24 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methotrexate and Adalimumab in people with Rheumatoid Arthritis, run by Keio University at 24 sites in 3 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 10 inclusion and 13 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 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Japan, South Korea, Taiwan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Simple Disease Activity Index (SDAI) Remission Rate at Week 48 in mFAS (time frame: Week 48). 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 NCT03505008, which also lists 2 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 6 Mar 2025.