Rheumatoid Arthritis (RA)UPWARDSNCT04267536
An Observational Study to Evaluate Impact of CRP-Level on Real World Effectiveness of Upadacitinib as Monotherapy or in Combination With MTX in Adult Participants With Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis (RA), run by AbbVie at 52 sites in Germany.
Trial summary
Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. RA can reduce the ability to perform everyday tasks. This study assesses whether C-reactive protein (CRP)-level has an impact on achieving remission with upadacitinib when used alone or in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- How many people
- 534 participants
- Where
- 52 sitesGermany
- Study dates
- 6 Feb 2020to 1 Feb 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult Participants with moderate to severe rheumatoid arthritis (RA)
Who may be able to join
- Diagnosis of moderate to severe active rheumatoid arthritis (RA) upon judgment of the treating physician.
- Swollen Joint Count (SJC) >= 3 of 28 joints of the Disease Activity Score (DAS)28.
- Measurement of C-Reactive Protein (CRP)-level at Baseline (BL) or <= 4 weeks prior to BL at a timepoint when the Prednisolone equivalent dose of Glucocorticoid treatment was <= 10 mg/day for at least 7 days.
- Upadacitinib treatment is indicated as per local Summary of Product characteristics (SmPC).
- Decision on the treatment with Upadacitinib was made prior to any decision to approach the patient to participate in this study.
Who cannot join
- Participants who cannot be treated with Upadacitinib according to the local Upadacitinib SmPC.
- Prior treatment with Upadacitinib.
- Treatment with Sarilumab or Tocilizumab within the last 8 weeks before the CRP level for inclusion was measured.
- Participants currently participating in interventional research.
- Participants who are unwilling or unable to complete the patient reported questionnaires.
Trial locations and contacts
52 sites in 1 country.
52 sites in 1 country
Germany52 sites
Kupka & Kupka, Altenburg, DE /ID# 218413
Altenburg, 04600
Marycz, Amberg, DE /ID# 220808
Amberg, 92224
Rheumapraxis am Webereck /ID# 218712
Augsburg, 86157
MVZ Weserbergland /ID# 220809
Bad Pyrmont, 31812
Internistische-rheumatologische Praxisgemeinschaft /ID# 218540
Bayreuth, 95444
Bozorg-Doagoo, Berlin, DE /ID# 218431
Berlin, 10713
Praxis Dr. Silke Zinke /ID# 218433
Berlin, 13055
Eisterhues, Braunschweig, DE /ID# 218532
Braunschweig, 38100
Medizinische Versorgungszentren Burghausen Altoetting /ID# 221385
Burghausen, 84489
Med Versorgungszentrum AGILOMED /ID# 218538
Chemnitz, 09130
Dres. Schuh /ID# 218541
Coburg, 96450
Praxis Dr. Lüthke /ID# 218900
Dresden, Saxony, 01097
Rheumatologisches MVZ Dresden /ID# 218411
Dresden, 01109
Rheumapraxis Düren /ID# 224950
Düren, 52355
Strothmeyer & Scheulen /ID# 218426
Düsseldorf, 40211
Praxis Dilltal /ID# 218427
Ehringshausen, 35630
Praxisgemeinschaft Rheumatologie Nephrologie Erlangen /ID# 222579
Erlangen, 91056
Dres. Waehrisch/Flaxenberg /ID# 218711
Essen, 45326
Michael Mueller, Freiberg, DE /ID# 218414
Freiberg, 09599
Praxis Dr. Kuehne /ID# 221389
Haldensleben I, 39340
Praxis Dr. Liebhaber /ID# 218899
Halle, 06128
Aries, Hamburg, DE /ID# 220804
Hamburg, 22767
Stille, Hanover, DE /ID# 218429
Hanover, 30161
Medizinische Hochschule Hannover /ID# 222068
Hanover, 30625
Heilig, Heidelberg, DE /ID# 221391
Heidelberg, 69120
Rheumazentrum Ruhrgebiet /ID# 221388
Herne, North Rhine-Westphalia, 44649
Praxis K. Pagel /ID# 218714
Hoppegarten, 15366
Hamann & Teich & Boche,Leipzig /ID# 218531
Leipzig, 04109
Schwarze/Haeder, Leipzig, DE /ID# 218412
Leipzig, 04129
Dres. Teipel/Toussaint/Saech /ID# 223969
Leverkusen, 51373
Aurich & Sieburg, Magdeburg /ID# 220811
Magdeburg, 39104
Harmuth, Marktredwitz, DE /ID# 218715
Marktredwitz, 95615
Praxis Dres. Kellerer/Kellerer/Krüger /ID# 218428
Munich, Bavaria, 81541
Prof-med-stud.de /ID# 218534
Munich, 80935
Praxis Dr. med Thilo Klopsch /ID# 218535
Neubrandenburg, 17033
Praxis Hein & Gess /ID# 218716
Nienburg, 31582
Praxis Hein & Gess /ID# 218896
Nienburg, 31582
Elisabeth-Klinik Bigge /ID# 218425
Olsberg, 59939
MVZ für Rheumatologie Dr. M. Welcker GmbH /ID# 218543
Planegg, 82152
Rheumahaus Studien GbR, Potsdam, DE /ID# 218430
Potsdam, Brandenburg, 14467
Knappschaftsklinikum Saar /ID# 218901
Püttlingen, 66346
Rheumazentrum Ratingen /ID# 218897
Ratingen, 40882
Rheumatologische Gemeinschaftspraxis Schwerin /ID# 218432
Schwerin, 19053
Melzer, Seesen, DE /ID# 220803
Seesen, 38723
Rheumatologische Schwerpunktpraxis /ID# 218415
Stuttgart, 70372
Bruederkrankenhaus Trier /ID# 221393
Trier, 54292
Praxis Dr. Haas /ID# 218423
Tübingen, 72072
Praxis Dr. Rinaldi /ID# 218424
Ulm, Baden-Wurttemberg, 89073
Rheumathologie Ulm /ID# 218539
Ulm, 89073
Krankenhaus St. Josef /ID# 221392
Wuppertal, 42105
Praxis Barmen /ID# 218895
Wuppertal, 42285
Fricke-Wagner, Zwickau, DE /ID# 218533
Zwickau, 08060
About this study
Official title: UPwArds - Post Marketing Observational Study to Evaluate the Impact of CRP-Level on the Real World Effectiveness of UPadacitinib When Used in MonotherApy or in Combination With MTX in Patients With RheumatoiD ArthritiS
Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. RA can reduce the ability to perform everyday tasks. This study assesses whether C-reactive protein (CRP)-level has an impact on achieving remission with upadacitinib when used alone or in combination with methotrexate (MTX). This study will also assess the reduction in pain, morning stiffness, fatigue, functionality, health status and impact of RA.
CRP is an indicator of inflammation and often used for disease activity monitoring during RA treatment. Upadacitinib is a Janus kinase (JAK) inhibitor indicated for the treatment of adults with moderately to severely active RA who have had an inadequate response or intolerance to methotrexate. This study has two groups - upadacitinib monotherapy and combination. Adult participants with moderate to severe RA will be enrolled. Around 500 participants will be enrolled in the study in multiple sites within Germany.
Read more
Participants will receive upadacitinib alone or in combination with MTX per their physicians' usual prescription. Individual data will be collected for 12 months.
No additional study-related tests will be conducted during the routine physician visits. Only data which are routinely collected during a regular visit will be utilized for this study.
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- Rheumatoid Arthritis (RA), Upadacitinib, RINVOQ, Methotrexate (MTX), ABT-494, C-reactive protein (CRP)
- Medical subject headings
- Arthritis, Rheumatoid
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 treated with upadacitinib monotherapy | Participants will receive upadacitinib for 12 months as prescribed by the physician | |
| Participants treated with upadacitinib in combination with MTX | Participants will receive upadacitinib in combination with MTX as prescribed by the physician for 12 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Remission
Remission is defined as clinical disease activity index (CDAI) <=2.8
Measured: 6 Months
Secondary outcomes (26)
Percentage of Participants Achieving Remission
Remission is defined as the disease activity score at 28 joints (DAS28)-C-Reactive protein (CRP)<2.6, DAS28- erythrocyte sedimentation rate (ESR)<2.6, simplified disease activity index (SDAI)<=3.3, CDAI<=2.8, Boolean.
Measured: Up to 12 Months
Percentage of Participants Achieving Low Disease Activity (LDA)
LDA is defined as DAS28-CRP<3.2, DAS28-ESR<3.2, SDAI <=11, CDAI<=10
Measured: Up to 12 Months
Mean Change From Baseline in CDAI
The CDAI is a validated measure of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale (VAS) from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 (lowest disease activity) to 76 (highest disease activity).
Measured: Up to 12 Months
Mean Change From Baseline in SDAI
The SDAI is a validated measure of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 (lowest disease activity) to 86 (highest disease activity).
Measured: Up to 12 Months
Mean Change From Baseline in DAS28-CRP
The Disease Activity Score (DAS) 28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 (lowest disease activity) to 10 (highest disease activity).
Measured: Up to 12 Months
Mean Change From Baseline in DAS28-ESR
The Disease Activity Score (DAS) 28 is a validated index of rheumatoid arthritis disease activity. Scores on the DAS28 range from 0 (lowest disease activity) to 10 (highest disease activity).
Measured: Up to 12 Months
Percentage of Participants Achieving Pain Reduction (Improvement by 30 %)
Improvement in pain reduction is assessed by numeric rating scale (NRS). The NRS of Pain sheet will be filled out in the office by participants at the designated visits.
Measured: Up to 12 Months
Percentage of Participants Achieving Pain Reduction (Improvement by 50 %)
Improvement in pain reduction is assessed by numeric rating scale (NRS). The NRS of Pain sheet will be filled out in the office by participants at the designated visits.
Measured: Up to 12 Months
Percentage of Participants Achieving Pain Reduction (Improvement by 70 %)
Improvement in pain reduction is assessed by numeric rating scale (NRS). The NRS of Pain sheet will be filled out in the office by participants at the designated visits.
Measured: Up to 12 Months
Mean Change From Baseline in Pain
The NRS of Pain sheet will be filled out in the office by participants at the designated visits.
Measured: Up to 12 Months
Percentage of Participants Achieving Fatigue Reduction (Improvement by 30 %)
Improvement in fatigue reduction is assessed by numeric rating scale (NRS). The NRS of fatigue sheet will be filled out in the office by participants at the designated visits.
Measured: Up to 12 Months
Percentage of Participants Achieving Fatigue Reduction (Improvement by 50 %)
Improvement in fatigue reduction is assessed by numeric rating scale (NRS). The NRS of fatigue sheet will be filled out in the office by participants at the designated visits.
Measured: Up to 12 Months
Percentage of Participants Achieving Fatigue Reduction (Improvement by 70 %)
Improvement in fatigue reduction is assessed by numeric rating scale (NRS). The NRS of fatigue sheet will be filled out in the office by participants at the designated visits.
Measured: Up to 12 Months
Mean Change From Baseline in Fatigue
Change in Fatigue is assessed by numeric rating scale (NRS). The NRS of fatigue sheet will be filled out in the office by participants at the designated visits.
Measured: Up to 12 Months
Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID)
RAID is a tool for assessment of disease activity purely based on a patient questionnaire.
Measured: Up to 12 Months
Percentage of Participants Achieving RAID <= 3
RAID is a tool for assessment of disease activity purely based on a patient questionnaire.
Measured: Up to 12 Months
Percentage of Participants Achieving RAID > 3 and <=4
RAID is a tool for assessment of disease activity purely based on a patient questionnaire.
Measured: Up to 12 Months
Percentage of Participants Achieving RAID > 4 and <=6
RAID is a tool for assessment of disease activity purely based on a patient questionnaire.
Measured: Up to 12 Months
Percentage of Participants Achieving RAID > 6
RAID is a tool for assessment of disease activity purely based on a patient questionnaire.
Measured: Up to 12 Months
Change From Baseline in Morning Stiffness Severity
Morning stiffness severity was assessed by a numeric rating-scale (NRS). Participants rated the severity of morning stiffness during the past week from 0 to 10 with 0 representing "not severe" and 10 "very severe".
Measured: Up to 12 Months
Change From Baseline in Morning Stiffness Duration
The duration of morning stiffness was reported by participants as the average daily length during the past week in minutes (from time of awaking to time of maximal improvement).
Measured: Up to 12 Months
Change From Baseline in Functionality (FFbH)
A self-administered patient questionnaire used to assess patient function based on 18 questions. The numerically coded responses to the questions are added to provide a total patient score.
Measured: Up to 12 Months
Change From Baseline in Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a 9-item questionnaire for assessing the severity of depression. Each question is answered on a scale from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27, where higher scores indicate more severe depression.
Measured: Up to 12 Months
Percentage of Participants With Minimal Clinically Important Difference (MCID) in PHQ-9
MCID is defined as the at least 5 points difference from baseline in PHQ-9. The PHQ-9 is a 9-item questionnaire for assessing the severity of depression.
Measured: Up to 12 Months
Percentage of Participants With Low Disease Activity (LDA) or Remission Without Actual Concomitant MTX
LDA is defined as DAS28 < 3.2, CDAI<=10, SDAI <11. Remission is defined as DAS28<2.6, CDAI<=2.8; Boolean Remission.
Measured: Up to 12 Months
Percentage of Participants With LDA or Remission With Actual Concomitant MTX
LDA is defined as DAS28 < 3.2, CDAI<=10, SDAI <11. Remission is defined as DAS28<2.6, CDAI<=2.8; Boolean Remission.
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 posted13 Feb 2020
- Study start6 Feb 2020
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- 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
- 534 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267536
- Sponsor's protocol ID
- P20-078
- Acronym
- UPWARDS
- Status last verified
- Jan 2023
- First submitted
- 11 Feb 2020
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UPwArds - Post Marketing Observational Study to Evaluate the Impact of CRP-Level on the Real World Effectiveness of UPadacitinib When Used in MonotherApy or in Combination With MTX in Patients With RheumatoiD ArthritiS
- ClinicalTrials.gov ID
- NCT04267536
- Acronym / sponsor ID
- UPWARDS / P20-078
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- Rheumatoid Arthritis (RA), Upadacitinib, RINVOQ, Methotrexate (MTX), ABT-494, C-reactive protein (CRP)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 534 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2020 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 13 Feb 2020 (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.
Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. RA can reduce the ability to perform everyday tasks. This study assesses whether C-reactive protein (CRP)-level has an impact on achieving remission with upadacitinib when used alone or in combination with methotrexate (MTX). This study will also assess the reduction in pain, morning stiffness, fatigue, functionality, health status and impact of RA.
CRP is an indicator of inflammation and often used for disease activity monitoring during RA treatment. Upadacitinib is a Janus kinase (JAK) inhibitor indicated for the treatment of adults with moderately to severely active RA who have had an inadequate response or intolerance to methotrexate. This study has two groups - upadacitinib monotherapy and combination. Adult participants with moderate to severe RA will be enrolled. Around 500 participants will be enrolled in the study in multiple sites within Germany.
Participants will receive upadacitinib alone or in combination with MTX per their physicians' usual prescription. Individual data will be collected for 12 months.
No additional study-related tests will be conducted during the routine physician visits. Only data which are routinely collected during a regular visit will be utilized for this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants treated with upadacitinib monotherapy | – | –Participants will receive upadacitinib for 12 months as prescribed by the physician |
| Participants treated with upadacitinib in combination with MTX | – | –Participants will receive upadacitinib in combination with MTX as prescribed by the physician for 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Participants with moderate to severe rheumatoid arthritis (RA)
Key inclusion criteria (5 listed)
- Diagnosis of moderate to severe active rheumatoid arthritis (RA) upon judgment of the treating physician.
- Swollen Joint Count (SJC) >= 3 of 28 joints of the Disease Activity Score (DAS)28.
- Measurement of C-Reactive Protein (CRP)-level at Baseline (BL) or <= 4 weeks prior to BL at a timepoint when the Prednisolone equivalent dose of Glucocorticoid treatment was <= 10 mg/day for at least 7 days.
- Upadacitinib treatment is indicated as per local Summary of Product characteristics (SmPC).
- Decision on the treatment with Upadacitinib was made prior to any decision to approach the patient to participate in this study.
Key exclusion criteria (5 listed)
- Participants who cannot be treated with Upadacitinib according to the local Upadacitinib SmPC.
- Prior treatment with Upadacitinib.
- Treatment with Sarilumab or Tocilizumab within the last 8 weeks before the CRP level for inclusion was measured.
- Participants currently participating in interventional research.
- Participants who are unwilling or unable to complete the patient reported questionnaires.
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
Percentage of Participants Achieving Remission
Time frame: 6 Months
Remission is defined as clinical disease activity index (CDAI) <=2.8
26 secondary outcomes
Percentage of Participants Achieving Remission
Time frame: Up to 12 Months
Percentage of Participants Achieving Low Disease Activity (LDA)
Time frame: Up to 12 Months
Mean Change From Baseline in CDAI
Time frame: Up to 12 Months
Mean Change From Baseline in SDAI
Time frame: Up to 12 Months
Mean Change From Baseline in DAS28-CRP
Time frame: Up to 12 Months
Mean Change From Baseline in DAS28-ESR
Time frame: Up to 12 Months
Percentage of Participants Achieving Pain Reduction (Improvement by 30 %)
Time frame: Up to 12 Months
Percentage of Participants Achieving Pain Reduction (Improvement by 50 %)
Time frame: Up to 12 Months
Percentage of Participants Achieving Pain Reduction (Improvement by 70 %)
Time frame: Up to 12 Months
Mean Change From Baseline in Pain
Time frame: Up to 12 Months
Percentage of Participants Achieving Fatigue Reduction (Improvement by 30 %)
Time frame: Up to 12 Months
Percentage of Participants Achieving Fatigue Reduction (Improvement by 50 %)
Time frame: Up to 12 Months
Percentage of Participants Achieving Fatigue Reduction (Improvement by 70 %)
Time frame: Up to 12 Months
Mean Change From Baseline in Fatigue
Time frame: Up to 12 Months
Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID)
Time frame: Up to 12 Months
Percentage of Participants Achieving RAID <= 3
Time frame: Up to 12 Months
Percentage of Participants Achieving RAID > 3 and <=4
Time frame: Up to 12 Months
Percentage of Participants Achieving RAID > 4 and <=6
Time frame: Up to 12 Months
Percentage of Participants Achieving RAID > 6
Time frame: Up to 12 Months
Change From Baseline in Morning Stiffness Severity
Time frame: Up to 12 Months
Change From Baseline in Morning Stiffness Duration
Time frame: Up to 12 Months
Change From Baseline in Functionality (FFbH)
Time frame: Up to 12 Months
Change From Baseline in Patient Health Questionnaire (PHQ-9)
Time frame: Up to 12 Months
Percentage of Participants With Minimal Clinically Important Difference (MCID) in PHQ-9
Time frame: Up to 12 Months
Percentage of Participants With Low Disease Activity (LDA) or Remission Without Actual Concomitant MTX
Time frame: Up to 12 Months
Percentage of Participants With LDA or Remission With Actual Concomitant MTX
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 26 Jan 2023.
- Individual participant dataSharing planned: Undecided
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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.
ABBVIE INC. study director
AbbVie
52 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis (RA), run by AbbVie at 52 sites in Germany.
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 5 inclusion and 5 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 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in Germany. 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?
Percentage of Participants Achieving Remission (time frame: 6 Months). 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 26 Jan 2023.