Back to resultsSafety and Efficacy of Itacitinib in Adults With Systemic Sclerosis (SCLERITA)
Primary Purpose
Systemic Sclerosis
Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Itacitinib
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Sclerosis focused on measuring Systemic sclerosis, Itacitinib
Eligibility Criteria
Inclusion Criteria:
- Adult patient (≥18 years old)
- Patient with a diagnosis of diffuse SSc, as defined by the American College of Rheumatology / EULAR 2013 criteria,
- Patient with a SSc disease duration of less than 36 months (defined as time from first non-Raynaud phenomenon manifestation) or with an active SSc disease, as defined by EUSTAR disease activity score,
- Patient with a modified Rodnan skin score (mRSS) ≥ 10 and ≤ 35 units at screening,
- Negative pregnancy test for woman of childbearing potential, woman of childbearing potential should have reliable contraception for the 12 months' duration of the study,
- Patient able to give written informed consent prior to participation in the study,
- Affiliation to a social security scheme (profit or being entitled).
Exclusion Criteria:
- Previous treatment with itacitinib or a Janus kinase (JAK) inhibitor,
- Contra-indications to itacitinib or Janus kinase inhibitor,
- Failure to sign the informed consent or unable to consent
- Patient participating in another investigational therapeutic study,
- Current, or history of recurrent infections, including HBV, HCV, HIV,
- Patient with other uncontrolled diseases, including drug or alcohol abuse, severe psychiatric diseases, that could interfere with participation in the trial according to the protocol,
- Patient suspected not to be observant to the proposed treatments,
- Patient who have white blood cell count ≤ 4,000/mm3,
- Patient who have platelet count ≤ 100,000/mm3,
- Patients who have ALT or AST level greater that 3 times the upper limit of normal,
- Patient who have triglyceride level greater than 5g/L
- Pregnant or breastfeeding woman,
- Protected adults (including individual under guardianship by court order),
- Patient receiving or having received mycophenolate mofetil or methotrexate within the last month (possible inclusion beyond one month),
- Patient receiving or having received cyclophosphamide or rituximab within the last three months (possible inclusion beyond 3 months),
- Patient receiving or having received a biotherapy (anti-TNF, abatacept or tocilizumab) in the last 3 months (possible inclusion beyond 3 months)
Sites / Locations
- CH AmiensRecruiting
- CHU AngersRecruiting
- CHU AnnecyRecruiting
- Avicenne HospitalRecruiting
- CHU BordeauxRecruiting
- Ambroise Paré hospitalRecruiting
- CHU CaenRecruiting
- CHU Gabriel MontpiedRecruiting
- Henry Mondor hospitalRecruiting
- CHU DijonRecruiting
- CHU GrenobleRecruiting
- CHU GrenobleRecruiting
- CHU LilleRecruiting
- CHU LimogesRecruiting
- CHU Lyon sudRecruiting
- Hôpital NordRecruiting
- La Timone HospitalRecruiting
- La Timone HospitalRecruiting
- CHU Montpellier - rhumatologyRecruiting
- CHU Montpellier - St Eloi HospitalRecruiting
- CHU NancyRecruiting
- CHU NantesRecruiting
- Hospital Pasteur - CHU NiceRecruiting
- Saint Antoine Hospital
- Cochin HospitalRecruiting
- Hospital Croix St Simon
- CHU PoitiersRecruiting
- Robert Debré HospitalRecruiting
- Hôpital SudRecruiting
- CHU Rouen
- Nouvel Hospital CivilRecruiting
- Rangueil HospitalRecruiting
- CHU ToursRecruiting
- CH ValenciennesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Itacitinib
Placebo
Arm Description
200mg of oral Itacitinib everyday for 360 days.
Oral placebo everyday for 360 days.
Outcomes
Primary Outcome Measures
Change in modified Rodnan skin score (mRSS) at 360 days
performed by the same investigator at day 0 and day 360 and the change in mRSS will be calculated following the formula: ΔmRSS= mRSSd360 - mRSSd0.
To measure mRSS, skin thickness of the patient is rated by palpation at each of 17 anatomic sites using a scale of 0-3 (0 = normal skin; 1= mild thickness; 2= moderate thickness; 3=severe thickness with an inability to pinch the skin into a fold). The scores at each site are summed with a minimum of 0 and a maximum of 51 (17 sites)
Secondary Outcome Measures
Incidence of death
Incidence of Adverse Events
according to the Common Terminology Criteria for Adverse Events (CTCAE) toxicity grading scale
Incidence of Severe Adverse Events
according to the Common Terminology Criteria for Adverse Events (CTCAE) toxicity grading scale
Change in modified Rodnan skin score at 90, 180, 270 days
Proportion of patients who improved mRSS at 90, 180, 270 and 360 days
Proportion of patients with an active disease according to the European scleroderma trials and research group (EUSTAR)SSc activity score at 90, 180, 270 and 360 days
EUSTAR SSc activity index score from 0 to 10 - a cut-off ≥ 2.5 identifies patients with active disease
Change in the Combined Response Index in Diffuse Systemic Sclerosis (CRISS) score
composite response index
SSc disease activity
Physicians visual analogue scale range from 0 (min) to 10 (max) - 0=no activity, 10=maximum activity
Patients visual analogue scale range from 0 (min) to 10 (max) - 0=no activity, 10=maximum activity
Short Form-36 (SF-36) health questionnaire
self-administered questionnaire of 36 items assessing the following 8 domains : physical functioning, bodily pain, role limitations attributable to physical health problems, general health perceptions, mental health, role limitations to emotional problems, vitality and social functioning (scale from 0 to 100)
EurolQol-5Domain (EQ-5D) health questionnaire
self reported measure of quality of life - (scale from 0 to 100)
Health Assessment Questionnaire Disability Index (HAQ-DI) scale
self administered 20 questions- score range from 0 (no disability) to 3 (severe disability)
Full Information
NCT ID
NCT04789850
First Posted
February 10, 2021
Last Updated
March 27, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT04789850
Brief Title
Safety and Efficacy of Itacitinib in Adults With Systemic Sclerosis
Acronym
SCLERITA
Official Title
Safety and Efficacy of Itacitinib in Adults With Systemic Sclerosis: a Phase II, Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2023 (Actual)
Primary Completion Date
February 2026 (Anticipated)
Study Completion Date
February 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether itacitinib is safe and effective in the treatment of systemic sclerosis in adults.
Detailed Description
Systemic sclerosis (SSc) is a rare systemic autoimmune connective tissue-disease characterized by fibrosis, inflammation, and vasculopathy. SSc is responsible for skin fibrosis that can either be limited or diffuse. The latter phenotype of the disease is commonly associated with visceral involvement and therefore similar to graft versus host disease (GvHD) reaction. It can be life threatening in case of pulmonary or cardiovascular involvement. Nonetheless SSc remains a severe disease responsible for important disability and a poor quality of life.
There is a growing body of evidence that supports the implication of the JAK-STAT tyrosine kinases pathway in the activation of fibroblasts of patients with SSc. A genetic polymorphism of STAT4 was found to be associated with the diffuse form of the disease and inhibition of STAT4 gene is associated with a decrease in TGF-ß and IL-6 cytokines activation, which are two major cytokines implicated in SSc pathogenesis. Recently, Pedroza et al. confirmed the implication of STAT3 in skin fibrosis mechanisms. Indeed, the authors showed an enhanced activation of STAT3 and demonstrated in vivo that the inhibition of STAT3 phosphorylation prevented skin fibrosis in a murine model of SSc. These data were confirmed by a work of Zhang et al. who showed that the inhibition of JAK1 was also needed to prevent skin and lung fibrosis. Altogether these works confirmed the implication of the JAK pathway in fibrosis mechanism.
Itacitinib is a Janus kinase inhibitor that specifically targets JAK1 and decreases STAT3 phosphorylation. Itacitinib was shown to efficiently treat patients with myelofibrosis, rheumatoid arthritis, and chronic plaque psoriasis. Very interestingly, itacitinib efficacy has also been reported in patients with acute GvHD. Altogether these data and studies reinforced the investigator's working hypothesis.
The efficacy and safety of this proposal must be tested.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Sclerosis
Keywords
Systemic sclerosis, Itacitinib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Itacitinib
Arm Type
Experimental
Arm Description
200mg of oral Itacitinib everyday for 360 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral placebo everyday for 360 days.
Intervention Type
Drug
Intervention Name(s)
Itacitinib
Intervention Description
200 mg oral for 360 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
200 mg oral for 360 days
Primary Outcome Measure Information:
Title
Change in modified Rodnan skin score (mRSS) at 360 days
Description
performed by the same investigator at day 0 and day 360 and the change in mRSS will be calculated following the formula: ΔmRSS= mRSSd360 - mRSSd0.
To measure mRSS, skin thickness of the patient is rated by palpation at each of 17 anatomic sites using a scale of 0-3 (0 = normal skin; 1= mild thickness; 2= moderate thickness; 3=severe thickness with an inability to pinch the skin into a fold). The scores at each site are summed with a minimum of 0 and a maximum of 51 (17 sites)
Time Frame
360 days
Secondary Outcome Measure Information:
Title
Incidence of death
Time Frame
at 180 and 360 days
Title
Incidence of Adverse Events
Description
according to the Common Terminology Criteria for Adverse Events (CTCAE) toxicity grading scale
Time Frame
at 180 and 360 days
Title
Incidence of Severe Adverse Events
Description
according to the Common Terminology Criteria for Adverse Events (CTCAE) toxicity grading scale
Time Frame
at 180 and 360 days
Title
Change in modified Rodnan skin score at 90, 180, 270 days
Time Frame
at 90, 180 and 270 days
Title
Proportion of patients who improved mRSS at 90, 180, 270 and 360 days
Time Frame
At 90, 180, 270 and 360 days
Title
Proportion of patients with an active disease according to the European scleroderma trials and research group (EUSTAR)SSc activity score at 90, 180, 270 and 360 days
Description
EUSTAR SSc activity index score from 0 to 10 - a cut-off ≥ 2.5 identifies patients with active disease
Time Frame
At 90, 180, 270 and 360 days
Title
Change in the Combined Response Index in Diffuse Systemic Sclerosis (CRISS) score
Description
composite response index
Time Frame
At 180 and 360 days
Title
SSc disease activity
Description
Physicians visual analogue scale range from 0 (min) to 10 (max) - 0=no activity, 10=maximum activity
Patients visual analogue scale range from 0 (min) to 10 (max) - 0=no activity, 10=maximum activity
Time Frame
At 90, 180, 270 and 360 days
Title
Short Form-36 (SF-36) health questionnaire
Description
self-administered questionnaire of 36 items assessing the following 8 domains : physical functioning, bodily pain, role limitations attributable to physical health problems, general health perceptions, mental health, role limitations to emotional problems, vitality and social functioning (scale from 0 to 100)
Time Frame
At 0, 15, 90, 180, 270 and 360 days
Title
EurolQol-5Domain (EQ-5D) health questionnaire
Description
self reported measure of quality of life - (scale from 0 to 100)
Time Frame
At 0, 15, 90, 180, 270 and 360 days
Title
Health Assessment Questionnaire Disability Index (HAQ-DI) scale
Description
self administered 20 questions- score range from 0 (no disability) to 3 (severe disability)
Time Frame
At 0, 15, 90, 180, 270 and 360 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patient (≥18 years old)
Patient with a diagnosis of diffuse SSc, as defined by the American College of Rheumatology / EULAR 2013 criteria,
Patient with a SSc disease duration of less than 36 months (defined as time from first non-Raynaud phenomenon manifestation) or with an active SSc disease, as defined by EUSTAR disease activity score,
Patient with a modified Rodnan skin score (mRSS) ≥ 10 and ≤ 35 units at screening,
Negative pregnancy test for woman of childbearing potential, woman of childbearing potential should have reliable contraception for the 12 months' duration of the study,
Patient able to give written informed consent prior to participation in the study,
Affiliation to a social security scheme (profit or being entitled).
Exclusion Criteria:
Previous treatment with itacitinib or a Janus kinase (JAK) inhibitor,
Contra-indications to itacitinib or Janus kinase inhibitor,
Failure to sign the informed consent or unable to consent
Patient participating in another investigational therapeutic study,
Current, or history of recurrent infections, including HBV, HCV, HIV,
Patient with other uncontrolled diseases, including drug or alcohol abuse, severe psychiatric diseases, that could interfere with participation in the trial according to the protocol,
Patient suspected not to be observant to the proposed treatments,
Patient who have white blood cell count ≤ 4,000/mm3,
Patient who have platelet count ≤ 100,000/mm3,
Patients who have ALT or AST level greater that 3 times the upper limit of normal,
Patient who have triglyceride level greater than 5g/L
Pregnant or breastfeeding woman,
Protected adults (including individual under guardianship by court order),
Patient receiving or having received mycophenolate mofetil or methotrexate within the last month (possible inclusion beyond one month),
Patient receiving or having received cyclophosphamide or rituximab within the last three months (possible inclusion beyond 3 months),
Patient receiving or having received a biotherapy (anti-TNF, abatacept or tocilizumab) in the last 3 months (possible inclusion beyond 3 months)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin Chaigne, MD
Phone
+33 1 58 41 41 17
Email
benjamin.chaigne@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Audrey Béclin-Clabaux
Phone
+33 1 58 41 33 82
Email
audrey.clabaux@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc Mouthon, MD-PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Benjamin Chaigne, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Amiens
City
Amiens
ZIP/Postal Code
80000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine LOK, MD, PhD
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian LAVIGNE, MD
Facility Name
CHU Annecy
City
Annecy
ZIP/Postal Code
74370
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice BEREZNE, MD
Facility Name
Avicenne Hospital
City
Bobigny
ZIP/Postal Code
93022
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yurdagul UZUNHAN, MD, PhD
Facility Name
CHU Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Elise TRUCHETET, MD
Facility Name
Ambroise Paré hospital
City
Boulogne-Billancourt
ZIP/Postal Code
92100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laetitia COUTTE, MD
Facility Name
CHU Caen
City
Caen
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Achille AOUBA, MD, PhD
Facility Name
CHU Gabriel Montpied
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc ANDRE, MD, PhD
Facility Name
Henry Mondor hospital
City
Créteil
ZIP/Postal Code
94000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas LIMAL, MD
Facility Name
CHU Dijon
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine BERTHIER, MD, PhD
Facility Name
CHU Grenoble
City
Grenoble
ZIP/Postal Code
38700
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernard IMBERT, MD
Facility Name
CHU Grenoble
City
Grenoble
ZIP/Postal Code
38700
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurence BOUILLET, MD, PhD
Facility Name
CHU Lille
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric HACHULLA, MD, PhD
Facility Name
CHU Limoges
City
Limoges
ZIP/Postal Code
87000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Laure FAUCHAIS, MD, PhD
Facility Name
CHU Lyon sud
City
Lyon
ZIP/Postal Code
69310
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-christophe LEGA, MD, PhD
Facility Name
Hôpital Nord
City
Marseille
ZIP/Postal Code
13015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brigitte GRANEL, MD, PhD
Facility Name
La Timone Hospital
City
Marseille
ZIP/Postal Code
13385
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Aleth RICHARD, MD, PhD
Facility Name
La Timone Hospital
City
Marseille
ZIP/Postal Code
13385
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Robert HARLE, MD, PhD
Facility Name
CHU Montpellier - rhumatology
City
Montpellier
ZIP/Postal Code
34090
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques MOREL, MD, PhD
Facility Name
CHU Montpellier - St Eloi Hospital
City
Montpellier
ZIP/Postal Code
34090
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe GUILPAIN, MD, PhD
Facility Name
CHU Nancy
City
Nancy
ZIP/Postal Code
54035
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denis WAHL, MD
Facility Name
CHU Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian AGARD, MD, PhD
Facility Name
Hospital Pasteur - CHU Nice
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Viviane QUEYREL, MD
Facility Name
Saint Antoine Hospital
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arsène MEKINIAN, MD
Facility Name
Cochin Hospital
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Chaigne, MD
Phone
+33 1 58 41 41 17
Email
benjamin.chaigne@aphp.fr
First Name & Middle Initial & Last Name & Degree
Yannick ALLANORE, MD
Facility Name
Hospital Croix St Simon
City
Paris
ZIP/Postal Code
75020
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan LONDON, MD
Facility Name
CHU Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mickael MARTIN, MD, PhD
Facility Name
Robert Debré Hospital
City
Reims
ZIP/Postal Code
51100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amélie SERVETTAZ, MD
Facility Name
Hôpital Sud
City
Rennes
ZIP/Postal Code
35200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick JEGO, MD, PhD
Facility Name
CHU Rouen
City
Rouen
ZIP/Postal Code
76000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ygal BENHAMOU, MD, PhD
Facility Name
Nouvel Hospital Civil
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thierry MARTIN, MD, PhD
Facility Name
Rangueil Hospital
City
Toulouse
ZIP/Postal Code
31400
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grégory PUGNET, MD
Facility Name
CHU Tours
City
Tours
ZIP/Postal Code
37000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabeth DIOT, MD
Facility Name
CH Valenciennes
City
Valenciennes
ZIP/Postal Code
59300
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas QUEMENEUR, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
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Citation
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PubMed Identifier
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Fridman JS, Scherle PA, Collins R, Burn T, Neilan CL, Hertel D, Contel N, Haley P, Thomas B, Shi J, Collier P, Rodgers JD, Shepard S, Metcalf B, Hollis G, Newton RC, Yeleswaram S, Friedman SM, Vaddi K. Preclinical evaluation of local JAK1 and JAK2 inhibition in cutaneous inflammation. J Invest Dermatol. 2011 Sep;131(9):1838-44. doi: 10.1038/jid.2011.140. Epub 2011 Jun 16.
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PubMed Identifier
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Deverapalli SC, Rosmarin D. The use of JAK inhibitors in the treatment of progressive systemic sclerosis. J Eur Acad Dermatol Venereol. 2018 Aug;32(8):e328. doi: 10.1111/jdv.14876. Epub 2018 Mar 6. No abstract available.
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Gordon JK, Martyanov V, Franks JM, Bernstein EJ, Szymonifka J, Magro C, Wildman HF, Wood TA, Whitfield ML, Spiera RF. Belimumab for the Treatment of Early Diffuse Systemic Sclerosis: Results of a Randomized, Double-Blind, Placebo-Controlled, Pilot Trial. Arthritis Rheumatol. 2018 Feb;70(2):308-316. doi: 10.1002/art.40358. Epub 2017 Dec 29.
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Safety and Efficacy of Itacitinib in Adults With Systemic Sclerosis
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