Scleroderma, SystemicPhase 2NCT02283762
Efficacy and Safety of Riociguat in Patients With Systemic Sclerosis
A Phase 2 study testing Riociguat (Adempas, BAY63-2521) in people with Scleroderma, Systemic, run by Bayer at 59 sites in 15 countries.
Trial summary
To investigate if Riociguat is effective in the treatment of systemic sclerosis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleroderma, Systemic
- What is being tested?
- Riociguat (Adempas, BAY63-2521)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 59 sitesin 15 countries
- Study dates
- 15 Jan 2015to 28 Mar 2019
- Phase
- Phase 2
- 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
- Men or women aged 18 years and older
- Systemic sclerosis, as defined by ACR/EULAR (American College of Rheumatology/European League Against Rheumatism) 2013 criteria
- dcSSc (diffuse cutaneous systemic sclerosis) according to the LeRoy criteria, ie, skin fibrosis proximal to the elbows and knees in addition to acral fibrosis
- Disease duration of ≤ 18 months (defined as time from the first non-Raynaud's phenomenon manifestation)
- ≥ 10 and ≤ 22 mRSS (modified Rodnan skin score) units at the screening visit
- FVC (forced vital capacity) ≥ 45% of predicted at screening
Show all 9Show fewer
- DLCO (diffusion capacity of the lung for carbon monoxide) ≥ 40% of predicted (hemoglobin-corrected) at screening
- Negative serum pregnancy test in a woman of childbearing potential at the screening visit
- 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 since signing of the informed consent form until 30 (+5) days after the last study drug administration.
Who cannot join
- Limited cutaneous SSc (systemic sclerosis) at screening
- Major surgery (including joint surgery) within 8 weeks prior to screening
- Hepatic insufficiency classified as Child-Pugh C
- Patients with isolated AST or ALT >3xULN or bilirubin >2xULN can be included in the trial under the condition of additional monitoring during the trial
- Estimated glomerular filtration rate (eGFR) < 15 mL/min/1.73 m^2 (Modification of Diet in Renal Disease formula) or on dialysis at the screening visit. Patients entering the trial with eGFR 15-29 mL/min/1.73 m^2 will be undergo additional monitoring of renal function
- Any prior history of renal crisis
Show all 15Show fewer
- Sitting SBP (systolic blood pressure) < 95 mmHg at the screening visit
- Sitting heart rate < 50 beats per minute (BPM) at the screening visit
- Left ventricular ejection fraction < 40% prior to screening
- Any form of pulmonary hypertension as determined by right heart catheterization
- Pulmonary disease with FVC < 45% of predicted or DLCO (hemoglobin-corrected) < 40% of predicted at screening
- Active state of hemoptysis or pulmonary hemorrhage, including those events managed by bronchial artery embolization
- Not permitted prior and concomitant medication
- Pregnant or breast feeding women
- Women of childbearing potential not willing to use adequate contraception and not willing to agree to 4-weekly pregnancy testing from Visit 1 (first administration of study drug) onwards until 30 (+5) days after last study drug intake.
Trial locations and contacts
59 sites in 15 countries.
59 sites in 15 countries
United States10 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
Medical University of South Carolina Medical Center
Charleston, South Carolina, 29425
University of Connecticut Health Center
Farmington, Connecticut, 06030
Memorial Hermann-Texas Medical Center
Houston, Texas, 77030
UCLA David Geffen School of Medicine
Los Angeles, California, 90095-1670
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
Stanford University School of Medicine
Palo Alto, California, 94304
University of Utah Health Care
Salt Lake City, Utah, 84132
Mayo Clinic - Scottsdale
Scottsdale, Arizona, 85259-5404
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Australia5 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Monash Medical Centre
Clayton, Victoria, 3168
St Vincent's Hospital
Fitzroy, Victoria, 3065
Liverpool Hospital
Liverpool, New South Wales, 2170
Royal Perth Hospital
Perth, Western Australia, 6000
France5 sites
Hôpital Pellegrin - Bordeaux
Bordeaux, 33000
Centre Hospitalier Universitaire - Grenoble
Grenoble, 38043
Hopital Claude-Huriez CHRU
Lille, 59037
Cochin - Paris
Paris, 75674
CHU STRASBOURG - Hôpital de Hautepierre
Strasbourg, 67098
Italy5 sites
A.O.U. di Cagliari
Cagliari, Sardinia, 09042
A.O.U. Careggi
Florence, Tuscany, 50139
A.O. di Padova
Padova, Veneto, 35128
A.O.U. Pisana
Pisa, Tuscany, 56126
A.O.U. Policlinico Umberto I
Rome, Lazio, 00161
Japan5 sites
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, 113-8603
Gunma University Hospital
Maebashi, Gunma, 371-8511
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648
Tohoku University Hospital
Sendai, Miyagi, 980-8574
Institute of Rheumatology Tokyo Women's Medical University
Shinjuku-ku, Tokyo, 162-0054
United Kingdom5 sites
Ninewells Hospital
Dundee, DD1 9SY
Aintree University Hospital
Liverpool, L9 7AL
Royal Free Hospital
London, NW3 2QG
Freeman Hospital
Newcastle upon Tyne, Tyne and Wear, NE7 7DN
Hope Hospital
Salford, Manchester, M6 8HD
Canada4 sites
St. Joseph's Healthcare - Hamilton
Hamilton, Ontario, L8N 1Y2
Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, H3T1E2
Arthritis Program Research Group, Inc.
Newmarket, Ontario, L3Y 3R7
Mount Sinai Hospital
Toronto, Ontario, M5T 3L9
Germany4 sites
Kerckhoff-Klinik GmbH
Bad Nauheim, Hesse, 61231
Universitätsklinikum Köln
Cologne, North Rhine-Westphalia, 50937
Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, 89081
Turkey (Türkiye)4 sites
Cukurova Univ. Tip. Fak. Balcali Hastanesi
Adana, 01330
Hacettepe Universitesi Tip Fakultesi
Ankara
Istanbul Universitesi Istanbul Tip Fakultesi
Istanbul, 34093
Dokuz Eylul Universitesi Tip Fakultesi
Izmir, 35340
Belgium3 sites
CU Saint-Luc/UZ St-Luc
Bruxelles - Brussel, 1200
UZ Gent
Ghent, 9000
UZ Leuven Gasthuisberg
Leuven, 3000
Switzerland3 sites
Universitätsspital Basel
Basel
Kantonsspital St. Gallen
Sankt Gallen, Canton of St. Gallen, 9007
UniversitätsSpital Zürich
Zurich, 8091
Hungary2 sites
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, 7632
Netherlands2 sites
Universitair Medisch Centrum St. Radboud
Nijmegen, 6525 GA
University Medical Center Utrecht
Utrecht, 3584 CX
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)
To investigate if Riociguat is effective in the treatment of systemic sclerosis
- Conditions
- Scleroderma, Systemic
- Being tested
- Riociguat (Adempas, BAY63-2521), Placebo
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Riociguat (Adempas, BAY63-2521)Drug
Starting dose 0.5 mg TID, increase by 0.5 mg every 2 weeks until highest possible dose of 2.5 mg TID
PlaceboDrug
Sham-titration
| Study group | Role | What they receive |
|---|---|---|
| Riociguat | Experimental | Main treatment phase of 52 weeks: participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a-titration period of up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received sham-titration in a dose-titration period of up to 10 weeks followed by a maintenance period. Receives: Drug: Riociguat (Adempas, BAY63-2521) |
| Placebo | Placebo comparator | Main treatment phase of 52 weeks: participants received matching placebo tablets to riociguat as sham titration in a dose-titration period up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a dose-titration period of up to 10 weeks followed by a maintenance period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Modified Rodnan Skin Score (mRSS) to Week 52
The mRSS is a validated physical examination method for estimating skin thickness. It correlates with biopsy measures of collagen in the dermis and reflects prognosis and visceral involvement, especially in early disease. It is scored on 0 (normal) to 3+ (severe induration) ordinal scales over 17 body areas, with a maximum score of 51 (higher score means worse situation) and is used to categorize severity of SSc. A decrease in the mean change of mRSS shows mRSS improved.
Measured: Baseline to week 52
Secondary outcomes (5)
CRISS (American College of Rheumatology Composite Response Index for Clinical Trials) at Week 52 Reported as Number of Participants With a CRISS Probability >=0.60 or <0.60 From Baseline to Week 52
CRISS forms a composite response index consisting of SSc-related organ involvement and the following five variables: mRSS, FVC percent predicted, physician's and patient's global assessments, and HAQ-DI score (from SHAQ patient-reported outcome). The resulting index is a 2-step process that captures clinically meaningful worsening of internal organ involvement and the core variables that show change. Patients for whom the predicted CRISS probability was ≥ 0.60 were considered improved, while patients for whom the predicted probability was < 0.60 were considered not improved.
Measured: Week 52
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score to Week 52
The HAQ-DI is a composite measure from which a 'Standard Disability Index' score can be computed to assess a patient's disability level. Generally, a score of 0-1 represents mild to moderate difficulty, 1-2 moderate to severe disability and 2-3 severe to very severe disability. The HAQ-DI comprises 20 items that assess patient abilities across 8 functional activities: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each item is rated on a 4-point scale: 0=Without ANY difficulty, 1=With SOME difficulty, 2=With MUCH difficulty, 3=UNABLE to do. The 8 scores of the 8 sections are summed and divided by 8. In the event that one section is not completed by a subject then the summed score would be divided by 7. The final overall HAQ-DI score ranges from 0 to 3 and positive change indicates worse health-related quality of life (HRQoL).
Measured: Baseline to week 52
Change From Baseline in Patient's Global Assessment Score to Week 52
The patient's global assessments (a self-report) quantified the overall disease activity or severity of SSc, with scores ranging from 0 (good) to 10 (worse). Positive change in the patient's global assessments score indicates worsening.
Measured: Baseline to week 52
Change From Baseline in Physician's Global Assessment Score to Week 52
The physician's global assessments (reported by the physician) quantified the overall disease activity or severity of SSc, with scores ranging from 0 (good) to 10 (worse). Positive change in the physician's global assessments score indicates worsening.
Measured: Baseline to week 52
Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted to Week 52
Negative change in FVC percent predicted indicates worsening.
Measured: Baseline to week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study start15 Jan 2015
- Primary completion15 Dec 2017
- Study completion28 Mar 2019
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 (3)Papers the sponsor has linked to this study.
- Other trials for Scleroderma, SystemicStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 121 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
- NCT02283762
- Sponsor's protocol ID
- 16277
- Other IDs
- 2014-001353-16, 2014
- Status last verified
- Jan 2020
- First submitted
- 3 Nov 2014
- Last updated
- 5 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Distler O, Pope J, Denton C, Allanore Y, Matucci-Cerinic M, de Oliveira Pena J, Khanna D. RISE-SSc: Riociguat in diffuse cutaneous systemic sclerosis. Respir Med. 2017 Jan;122 Suppl 1:S14-S17. doi: 10.1016/j.rmed.2016.09.011. Epub 2016 Sep 28.
PubMed 27746061Khanna D, Kramer F, Hofler J, Ghadessi M, Sandner P, Allanore Y, Denton CP, Kuwana M, Matucci-Cerinic M, Pope JE, Atsumi T, Becvar R, Czirjak L, De Langhe E, Hachulla E, Ishii T, Ishikawa O, Johnson SR, Riccieri V, Schiopu E, Silver RM, Smith V, Stagnaro C, Steen V, Stevens W, Szucs G, Truchetet ME, Wosnitza M, Distler O. Biomarker analysis from the phase 2b randomized placebo-controlled trial of riociguat in early diffuse cutaneous systemic sclerosis. Rheumatology (Oxford). 2024 Nov 1;63(11):3124-3134. doi: 10.1093/rheumatology/keae150.
PubMed 38460548Distler O, Allanore Y, Denton CP, Kuwana M, Matucci-Cerinic M, Pope JE, Atsumi T, Becvar R, Czirjak L, Hachulla E, Ishii T, Ishikawa O, Johnson SR, De Langhe E, Stagnaro C, Riccieri V, Schiopu E, Silver RM, Smith V, Steen V, Stevens W, Szucs G, Truchetet ME, Wosnitza M, Laapas K, Kramer F, Khanna D. Riociguat in patients with early diffuse cutaneous systemic sclerosis (RISE-SSc): open-label, long-term extension of a phase 2b, randomised, placebo-controlled trial. Lancet Rheumatol. 2023 Nov;5(11):e660-e669. doi: 10.1016/S2665-9913(23)00238-2.
PubMed 38251533
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)
- ClinicalTrials.gov ID
- NCT02283762
- Acronym / sponsor ID
- 16277
- Conditions
- Scleroderma, Systemic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2015 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 28 Mar 2019 (actual)
- First posted
- 5 Nov 2014 (estimated)
- Results
- Posted 25 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate if Riociguat is effective in the treatment of systemic sclerosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Riociguat | Experimental | Drug: Riociguat (Adempas, BAY63-2521)Main treatment phase of 52 weeks: participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a-titration period of up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received sham-titration in a dose-titration period of up to 10 weeks followed by a maintenance period. |
| Placebo | Placebo comparator | Drug: PlaceboMain treatment phase of 52 weeks: participants received matching placebo tablets to riociguat as sham titration in a dose-titration period up to 10 weeks and a maintenance period of up to 42 weeks. Long-term extension phase: starting after the completion of the Main Treatment Phase in Week 52, participants received increasing doses of riociguat by 0.5 mg every 2 weeks up to 2.5 mg 3 times a day (TID) in a dose-titration period of up to 10 weeks followed by a maintenance period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men or women aged 18 years and older
- Systemic sclerosis, as defined by ACR/EULAR (American College of Rheumatology/European League Against Rheumatism) 2013 criteria
- dcSSc (diffuse cutaneous systemic sclerosis) according to the LeRoy criteria, ie, skin fibrosis proximal to the elbows and knees in addition to acral fibrosis
- Disease duration of ≤ 18 months (defined as time from the first non-Raynaud's phenomenon manifestation)
- ≥ 10 and ≤ 22 mRSS (modified Rodnan skin score) units at the screening visit
Key exclusion criteria (15 listed)
- Limited cutaneous SSc (systemic sclerosis) at screening
- Major surgery (including joint surgery) within 8 weeks prior to screening
- Hepatic insufficiency classified as Child-Pugh C
- Patients with isolated AST or ALT >3xULN or bilirubin >2xULN can be included in the trial under the condition of additional monitoring during the trial
- Estimated glomerular filtration rate (eGFR) < 15 mL/min/1.73 m^2 (Modification of Diet in Renal Disease formula) or on dialysis at the screening visit. Patients entering the trial with eGFR 15-29 mL/min/1.73 m^2 will be undergo additional monitoring of renal function
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)Starting dose 0.5 mg TID, increase by 0.5 mg every 2 weeks until highest possible dose of 2.5 mg TID | Drug | Riociguat |
| PlaceboSham-titration | Drug | Placebo |
Primary outcome
Change From Baseline in Modified Rodnan Skin Score (mRSS) to Week 52
Time frame: Baseline to week 52
The mRSS is a validated physical examination method for estimating skin thickness. It correlates with biopsy measures of collagen in the dermis and reflects prognosis and visceral involvement, especially in early disease. It is scored on 0 (normal) to 3+ (severe induration) ordinal scales over 17 body areas, with a maximum score of 51 (higher score means worse situation) and is used to categorize severity of SSc. A decrease in the mean change of mRSS shows mRSS improved.
5 secondary outcomes
CRISS (American College of Rheumatology Composite Response Index for Clinical Trials) at Week 52 Reported as Number of Participants With a CRISS Probability >=0.60 or <0.60 From Baseline to Week 52
Time frame: Week 52
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score to Week 52
Time frame: Baseline to week 52
Change From Baseline in Patient's Global Assessment Score to Week 52
Time frame: Baseline to week 52
Change From Baseline in Physician's Global Assessment Score to Week 52
Time frame: Baseline to week 52
Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted to Week 52
Time frame: Baseline to week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27746061Distler O, Pope J, Denton C, Allanore Y, Matucci-Cerinic M, de Oliveira Pena J, Khanna D. RISE-SSc: Riociguat in diffuse cutaneous systemic sclerosis. Respir Med. 2017 Jan;122 Suppl 1:S14-S17. doi: 10.1016/j.rmed.2016.09.011. Epub 2016 Sep 28.
- Derived from this study: PubMed 38460548Khanna D, Kramer F, Hofler J, Ghadessi M, Sandner P, Allanore Y, Denton CP, Kuwana M, Matucci-Cerinic M, Pope JE, Atsumi T, Becvar R, Czirjak L, De Langhe E, Hachulla E, Ishii T, Ishikawa O, Johnson SR, Riccieri V, Schiopu E, Silver RM, Smith V, Stagnaro C, Steen V, Stevens W, Szucs G, Truchetet ME, Wosnitza M, Distler O. Biomarker analysis from the phase 2b randomized placebo-controlled trial of riociguat in early diffuse cutaneous systemic sclerosis. Rheumatology (Oxford). 2024 Nov 1;63(11):3124-3134. doi: 10.1093/rheumatology/keae150.
- Derived from this study: PubMed 38251533Distler O, Allanore Y, Denton CP, Kuwana M, Matucci-Cerinic M, Pope JE, Atsumi T, Becvar R, Czirjak L, Hachulla E, Ishii T, Ishikawa O, Johnson SR, De Langhe E, Stagnaro C, Riccieri V, Schiopu E, Silver RM, Smith V, Steen V, Stevens W, Szucs G, Truchetet ME, Wosnitza M, Laapas K, Kramer F, Khanna D. Riociguat in patients with early diffuse cutaneous systemic sclerosis (RISE-SSc): open-label, long-term extension of a phase 2b, randomised, placebo-controlled trial. Lancet Rheumatol. 2023 Nov;5(11):e660-e669. doi: 10.1016/S2665-9913(23)00238-2.
- Click here to find information about studies related to Bayer Healthcare products conducted in Europe.Link 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
59 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Riociguat (Adempas, BAY63-2521) in people with Scleroderma, Systemic, run by Bayer at 59 sites in 15 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 9 inclusion and 15 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 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in United States, Australia, France, Italy, Japan and 10 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 25 Jan 2019). 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?
Change From Baseline in Modified Rodnan Skin Score (mRSS) to Week 52 (time frame: Baseline to week 52). 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 NCT02283762, which also lists 3 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 5 Feb 2020.