Pulmonary Arterial HypertensionPhase 4REPLACENCT02891850
Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy
A Phase 4 study testing Riociguat (Adempas, BAY63-2521), Sildenafil and Tadalafil in people with Pulmonary Arterial Hypertension, run by Bayer at 81 sites in 21 countries.
Trial summary
To demonstrate the effectiveness of riociguat as replacement of phosphodiesterase-5 inhibitors (PDE-5i) therapy in pulmonary arterial hypertension (PAH) patients Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Riociguat (Adempas, BAY63-2521), Sildenafil and Tadalafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 81 sitesin 21 countries
- Study dates
- 11 Jan 2017to 3 Mar 2020
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged 18 to 75 years.
- Patients with symptomatic PAH with a pulmonary vascular resistance (PVR) > 400 dyn*sec*cm-5, mean pulmonary artery pressure ≥ 25 mmHg, and pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg as assessed by the most recent right heart catheterization (RHC) from medical history prior to screening to confirm the diagnosis. Alternatively, PCWP can be replaced by left ventricular end-diastolic pressure (≤ 15 mmHg). PAH of the following types:
- Idiopathic
- Hereditary
- Drug and toxin induced PAH
- Associated with PAH due to:
Show all 16Show fewer
- Connective tissue disease (CTD)
- Congenital heart disease, but only if the patient underwent surgical repair more than one year before enrolment
- Portal hypertension with liver cirrhosis (Note: patients with clinical relevant hepatic dysfunction are excluded; see exclusions related to disorders in organ function)
- Patients who are on stable doses of a PDE-5i and ERA combination therapy or on stable PDE-5i monotherapy 6 weeks prior to and at randomization but not at treatment goal (tadalafil 20 to 40 mg once daily or sildenafil at least 60 mg daily dose).
- WHO FC III at screening and at randomization.
- 6MWD test between 165 m and 440 m at screening and at randomization.
- Stable dose of diuretics, if used, for at least 30 days prior to and at randomization.
- Patients who are able to understand and follow instructions and who are able to participate in the study for the entire study.
- Women of childbearing potential must agree to use adequate contraception when sexually active. Adequate contraception is defined as any combination of at least 2 effective methods of birth control, of which at least 1 is a physical barrier (e.g. condom with hormonal contraception like implants or combined oral contraceptives, condom with intrauterine devices). This applies beginning with signing of the informed consent form until 30 (+5) days after the last administration of study drug.
- Patients must have given their written informed consent to participate in the study after having received adequate previous information and prior to any study-specific procedures.
Who cannot join
- Participation in another interventional clinical study within 30 days prior to screening.
- All types of PH (including PH-IIP) except subtypes of Dana Point Group I specified in the inclusion criteria.
- Previous treatment with riociguat.
- Pregnant women (i.e., positive serum ß-human-chorionic-gonadotropin test or other signs of pregnancy), or breast feeding women, or women with childbearing potential not using a combination of 2 effective contraception methods (as laid out in inclusion criterion) throughout the study.
- Patients with a medical disorder, condition, or history of such that would impair the patient's ability to participate or complete this study, in the opinion of the investigator.
- Relevant obstructive and restrictive or other lung diseases.
Show all 10Show fewer
- Patients with underlying medical disorders with an anticipated life expectancy below 2 years (e.g., active cancer disease with localized and/or metastasized tumor mass).
- Cardiovascular exclusion criteria like left ventricular disease, coronary heart disease or stroke within previous 3 months.
- Patients with hypersensitivity to the investigational drug or any of the excipients.
- Patients unable to perform a valid 6MWD test (e.g., orthopedic disease, peripheral artery occlusive disease, which affects the patient's ability to walk). Note: Patients, who require walking aids, may be included if in the opinion of the investigator the walking distance is not impaired. Patients with a variance of more than 15% between the screening and the randomization (i.e., baseline) 6MWD test.
Trial locations and contacts
81 sites in 21 countries.
81 sites in 21 countries
United States17 sites
Study site
Cleveland, Ohio, 44195
Study site
Dallas, Texas, 75390
Study site
Detroit, Michigan, 48202
Study site
Kansas City, Kansas, 66103
Study site
Louisville, Kentucky, 40202
Study site
Mineola, New York, 11501
Study site
Nashville, Tennessee, 37232
Study site
New York, New York, 10003
Study site
Newark, New Jersey, 07112
Study site
Orlando, Florida, 32803
Study site
Phoenix, Arizona, 85012
Study site
Richmond, Virginia, 23225
Study site
Rochester, New York, 14623
Study site
Sacramento, California, 95817
Study site
Troy, Michigan, 48085
Study site
Tucson, Arizona, 85724
Study site
Weston, Florida, 33331
Germany13 sites
Study site
Berlin, 14050
Study site
Cologne, North Rhine-Westphalia, 50937
Study site
Dresden, Saxony, 01307
Study site
Giessen, 35390
Study site
Hamburg, 20246
Study site
Hanover, Lower Saxony, 30625
Study site
Heidelberg, Baden-Wurttemberg, 69126
Study site
Homburg, Saarland, 66421
Study site
Leipzig, Saxony, 04103
Study site
Lübeck, Schleswig-Holstein, 23538
Study site
München, Bavaria, 80639
Study site
München, Bavaria, 81377
Study site
Würzburg, Bavaria, 97074
Brazil6 sites
Study site
Belo Horizonte, Minas Gerais, 30130-100
Study site
Belo Horizonte, Minas Gerais, 30441-070
Study site
Blumenal, Santa Catarina, 89030-101
Study site
Porto Alegre, Rio Grande do Sul, 90050-170
Study site
São Paulo, 04023-061
Study site
São Paulo, 05403-000
Italy4 sites
Study site
Naples, Campania, 80131
Study site
Palermo, Sicily, 90127
Study site
Pavia, Lombardy, 27100
Study site
Rome, Lazio, 00161
South Korea4 sites
Study site
Seoul, 03722
Study site
Seoul, 110-744
Study site
Seoul, 135-710
Study site
Seoul, 138-736
Spain4 sites
Study site
Barcelona, 08035
Study site
Barcelona, 08036
Study site
Las Palmas de Gran Canaria, Las Palmas, 35020
Study site
Toledo, 45004
Turkey (Türkiye)4 sites
Study site
Ankara, 06100
Study site
Istanbul, 34-300
Study site
Istanbul, 34093
Study site
Izmir, 34098
United Kingdom4 sites
Study site
Clydebank, West Dunbartonshire, G81 4DY
Study site
London, NW3 2QG
Study site
London, SW3 6NP
Study site
Sheffield, S10 2JF
Greece3 sites
Study site
Chaïdári, 124 62
Study site
Thessaloniki, 546 36
Study site
Thessaloniki, 57010
Japan3 sites
Study site
Bunkyo-ku, Tokyo, 113-8655
Study site
Nagoya, Aichi-ken, 467-8602
Study site
Sendai, Miyagi, 980-8574
Portugal3 sites
Study site
Almada, Lisbon District, 2801-951
Study site
Coimbra, 3000-075
Study site
Lisbon, 1649-035
Taiwan3 sites
Study site
Kaoshiung, 81346
Study site
Tainan, 704
Study site
Taipei, 10016
Netherlands2 sites
Study site
Amsterdam, 1081 HV
Study site
Nijmegen, 6500HB
About this study
Official title: A Prospective, Randomized, International, Multicenter, Double-arm, Controlled, Open-label Study of Riociguat in Patients With Pulmonary Arterial Hypertension (PAH) Who Are on a Stable Dose of Phosphodiesterase-5 Inhibitors (PDE-5i) With or Without Endothelin Receptor Antagonist (ERA), But Not at Treatment Goal
To demonstrate the effectiveness of riociguat as replacement of phosphodiesterase-5 inhibitors (PDE-5i) therapy in pulmonary arterial hypertension (PAH) patients
Read the detailed description
Data from a previous single arm study (RESPITE) indicate that transition from PDE5i to riociguat may be feasible, safe and beneficial in patients not adequately responding to PDE5i.
REPLACE is a randomized controlled study to confirm the potential clinical benefit of transition from PDE5i to riociguat. Satisfactory clinical response in patients who are on a stable dose of phosphodiesterase-5inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal will be compared between one group of patients randomized to maintain current treatment and another group where the PDE5i is replaced by riociguat.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Riociguat (Adempas, BAY63-2521), Sildenafil, Tadalafil
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Riociguat (Adempas, BAY63-2521)Drug
Film-coated tablets will be used in this study at a dosage of 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg. Tablets will be administered orally.The starting dose is 1 mg TID; the intervals between drug intakes should be 6 to 8 hours. The dosage should be increased by 0.5 mg increments in 2 week intervals to 1.5 mg, 2.0 mg, and 2.5 mg TID (maximal total daily dose).
SildenafilDrug
Patients randomized to the control arm will continue to receive stable doses of tadalafil (daily dose 20 to 40 mg) or sildenafil (daily dose at least 60 mg) as well as other supportive treatments at the discretion of the investigator.
TadalafilDrug
Patients randomized to the control arm will continue to receive stable doses of tadalafil (daily dose 20 to 40 mg) or sildenafil (daily dose at least 60 mg) as well as other supportive treatments at the discretion of the investigator.
| Study group | Role | What they receive |
|---|---|---|
| Riociguat | Experimental | PDE5i treatment will be stopped and riociguat treatment initiated following a defined washout period with a starting dose of 1 mg riociguat TID followed by an 8 weeks dose adjustment phase according to the approved riociguat dose adjustment scheme. Receives: Drug: Riociguat (Adempas, BAY63-2521) |
| PDE-5i | Active comparator | Patients will continue to receive PDE5i treatment as well as other standard of care treatments at the discretion of the investigator up to Week 24. Patients in the experimental and active comparator treatment arms follow the same visit schedule. Receives: Drug: Sildenafil; Drug: Tadalafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Satisfactory Clinical Response at Week 24
The treatment is assessed as efficient (participants with satisfactory clinical response) in case at least 2 out of the following 3 criteria were fulfilled
- 6 Minute Walking Distance increase by ≥ 10% or ≥ 30 m from baseline to Week 24
- World Health Organization Functional Class (WHO FC) I or II at Week 24
- N-terminal pro-brain natriuretic peptide (NT-proBNP) reduction ≥ 30% from baseline to Week 24 (NT-proBNP ratio Week 24/baseline ≤ 0.7) and in absence of the defined criteria of clinical worsening
Measured: At Week 24
Secondary outcomes (4)
Change in 6 Minute Walking Distance (6MWD) With Last Observation Carried Forward From Baseline to 24 Weeks
Six-minute walk distance (6MWD) was conducted to test the physical limitations of the participant by assessing the participant's exercise capacity. The distance walked by the participant in 6 minutes was measured.
Measured: From baseline and up to 24 weeks
Change in N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) With Last Observation Carried Forward at Week 24
N-terminal pro-brain natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute congestive heart failure (CHF) and may be useful to establish prognosis in heart failure.
Measured: From baseline and up to 24 weeks
Change in World Health Organization Functional Class (WHO FC) With Last Observation Carried Forward From Baseline to Week 24
The participant's functional class was determined by using the WHO classification. Possible classes range from I (patients with pulmonary hypertension (PH) but without resulting limitation of physical activity) to IV (patients with PH with inability to carry out any physical activity without symptoms).
Measured: From baseline and up to 24 weeks
Number of Participants With Adjudicated Clinical Worsening at Week 24
Clinical worsening was defined as death of any cause, hospitalization due to worsening pulmonary arterial hypertension (PAH) (adjudicated) or disease progression (adjudicated).
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study start11 Jan 2017
- Primary completion29 Jan 2020
- Study completion3 Mar 2020
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 (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02891850
- Sponsor's protocol ID
- 18588
- Other IDs
- 2016-001067-36, 2016
- Acronym
- REPLACE
- Status last verified
- Jan 2021
- First submitted
- 26 Aug 2016
- Last updated
- 26 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- No
Publications
Hoeper MM, Al-Hiti H, Benza RL, Chang SA, Corris PA, Gibbs JSR, Grunig E, Jansa P, Klinger JR, Langleben D, McLaughlin VV, Meyer GMB, Ota-Arakaki J, Peacock AJ, Pulido T, Rosenkranz S, Vizza CD, Vonk-Noordegraaf A, White RJ, Chang M, Kleinjung F, Meier C, Paraschin K, Ghofrani HA, Simonneau G; REPLACE investigators. Switching to riociguat versus maintenance therapy with phosphodiesterase-5 inhibitors in patients with pulmonary arterial hypertension (REPLACE): a multicentre, open-label, randomised controlled trial. Lancet Respir Med. 2021 Jun;9(6):573-584. doi: 10.1016/S2213-2600(20)30532-4. Epub 2021 Mar 24.
PubMed 33773120
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, International, Multicenter, Double-arm, Controlled, Open-label Study of Riociguat in Patients With Pulmonary Arterial Hypertension (PAH) Who Are on a Stable Dose of Phosphodiesterase-5 Inhibitors (PDE-5i) With or Without Endothelin Receptor Antagonist (ERA), But Not at Treatment Goal
- ClinicalTrials.gov ID
- NCT02891850
- Acronym / sponsor ID
- REPLACE / 18588
- Conditions
- Pulmonary Arterial Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 11 Jan 2017 (actual)
- Primary completion
- 29 Jan 2020 (actual)
- Study completion
- 3 Mar 2020 (actual)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Posted 22 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate the effectiveness of riociguat as replacement of phosphodiesterase-5 inhibitors (PDE-5i) therapy in pulmonary arterial hypertension (PAH) patients
Detailed description
Data from a previous single arm study (RESPITE) indicate that transition from PDE5i to riociguat may be feasible, safe and beneficial in patients not adequately responding to PDE5i.
REPLACE is a randomized controlled study to confirm the potential clinical benefit of transition from PDE5i to riociguat. Satisfactory clinical response in patients who are on a stable dose of phosphodiesterase-5inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal will be compared between one group of patients randomized to maintain current treatment and another group where the PDE5i is replaced by riociguat.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Riociguat | Experimental | Drug: Riociguat (Adempas, BAY63-2521)PDE5i treatment will be stopped and riociguat treatment initiated following a defined washout period with a starting dose of 1 mg riociguat TID followed by an 8 weeks dose adjustment phase according to the approved riociguat dose adjustment scheme. |
| PDE-5i | Active comparator | Drug: Sildenafil, Drug: TadalafilPatients will continue to receive PDE5i treatment as well as other standard of care treatments at the discretion of the investigator up to Week 24. Patients in the experimental and active comparator treatment arms follow the same visit schedule. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male and female patients aged 18 to 75 years.
- Patients with symptomatic PAH with a pulmonary vascular resistance (PVR) > 400 dyn*sec*cm-5, mean pulmonary artery pressure ≥ 25 mmHg, and pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg as assessed by the most recent right heart catheterization (RHC) from medical history prior to screening to confirm the diagnosis. Alternatively, PCWP can be replaced by left ventricular end-diastolic pressure (≤ 15 mmHg). PAH of the following types:
- Patients who are on stable doses of a PDE-5i and ERA combination therapy or on stable PDE-5i monotherapy 6 weeks prior to and at randomization but not at treatment goal (tadalafil 20 to 40 mg once daily or sildenafil at least 60 mg daily dose).
- WHO FC III at screening and at randomization.
- 6MWD test between 165 m and 440 m at screening and at randomization.
Key exclusion criteria (10 listed)
- Participation in another interventional clinical study within 30 days prior to screening.
- All types of PH (including PH-IIP) except subtypes of Dana Point Group I specified in the inclusion criteria.
- Previous treatment with riociguat.
- Pregnant women (i.e., positive serum ß-human-chorionic-gonadotropin test or other signs of pregnancy), or breast feeding women, or women with childbearing potential not using a combination of 2 effective contraception methods (as laid out in inclusion criterion) throughout the study.
- Patients with a medical disorder, condition, or history of such that would impair the patient's ability to participate or complete this study, in the opinion of the investigator.
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 |
|---|---|---|
| Riociguat (Adempas, BAY63-2521)Film-coated tablets will be used in this study at a dosage of 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg. Tablets will be administered orally.The starting dose is 1 mg TID; the intervals between drug intakes should be 6 to 8 hours. The dosage should be increased by 0.5 mg increments in 2 week intervals to 1.5 mg, 2.0 mg, and 2.5 mg TID (maximal total daily dose). | Drug | Riociguat |
| SildenafilPatients randomized to the control arm will continue to receive stable doses of tadalafil (daily dose 20 to 40 mg) or sildenafil (daily dose at least 60 mg) as well as other supportive treatments at the discretion of the investigator. | Drug | PDE-5i |
| TadalafilPatients randomized to the control arm will continue to receive stable doses of tadalafil (daily dose 20 to 40 mg) or sildenafil (daily dose at least 60 mg) as well as other supportive treatments at the discretion of the investigator. | Drug | PDE-5i |
Primary outcome
Number of Participants With Satisfactory Clinical Response at Week 24
Time frame: At Week 24
The treatment is assessed as efficient (participants with satisfactory clinical response) in case at least 2 out of the following 3 criteria were fulfilled * 6 Minute Walking Distance increase by ≥ 10% or ≥ 30 m from baseline to Week 24 * World Health Organization Functional Class (WHO FC) I or II at Week 24 * N-terminal pro-brain natriuretic peptide (NT-proBNP) reduction ≥ 30% from baseline to Week 24 (NT-proBNP ratio Week 24/baseline ≤ 0.7) and in absence of the defined criteria of clinical worsening
4 secondary outcomes
Change in 6 Minute Walking Distance (6MWD) With Last Observation Carried Forward From Baseline to 24 Weeks
Time frame: From baseline and up to 24 weeks
Change in N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) With Last Observation Carried Forward at Week 24
Time frame: From baseline and up to 24 weeks
Change in World Health Organization Functional Class (WHO FC) With Last Observation Carried Forward From Baseline to Week 24
Time frame: From baseline and up to 24 weeks
Number of Participants With Adjudicated Clinical Worsening at Week 24
Time frame: Up to 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33773120Hoeper MM, Al-Hiti H, Benza RL, Chang SA, Corris PA, Gibbs JSR, Grunig E, Jansa P, Klinger JR, Langleben D, McLaughlin VV, Meyer GMB, Ota-Arakaki J, Peacock AJ, Pulido T, Rosenkranz S, Vizza CD, Vonk-Noordegraaf A, White RJ, Chang M, Kleinjung F, Meier C, Paraschin K, Ghofrani HA, Simonneau G; REPLACE investigators. Switching to riociguat versus maintenance therapy with phosphodiesterase-5 inhibitors in patients with pulmonary arterial hypertension (REPLACE): a multicentre, open-label, randomised controlled trial. Lancet Respir Med. 2021 Jun;9(6):573-584. doi: 10.1016/S2213-2600(20)30532-4. Epub 2021 Mar 24.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
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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.
Bayer Study Director study director
Bayer
81 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Riociguat (Adempas, BAY63-2521), Sildenafil and Tadalafil in people with Pulmonary Arterial Hypertension, run by Bayer at 81 sites in 21 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 16 inclusion and 10 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 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 81 sites in United States, Germany, Brazil, Italy, South Korea and 16 more countries. 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 22 Jan 2021). 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?
Number of Participants With Satisfactory Clinical Response at Week 24 (time frame: At Week 24). 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 NCT02891850, which also lists 1 linked publication.
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 Feb 2021.