## Protocol Section
### Identification Module
**NCT ID:** NCT03059979

**Brief Title:** The Effect of High Dose Methylprednisolone on Nailfold in Early Systemic Sclerosis ( SSc )

**Official Title:** Hit Hard and Early. The Effect of High Dose Methylprednisolone on Nailfold Capillary Changes and Biomarkers in Early SSc: a 12-week Randomised Explorative Double-blind Placebo-controlled Trial.

#### Organization Study ID Info
**ID:** HHaE
#### Organization
**Class:** OTHER
**Full Name:** Radboud University Medical Center
### Status Module
#### Completion Date
**Date:** 2021-07-01

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2019-11-29

**Type:** ACTUAL

**Last Update Submit Date:** 2019-11-27

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2021-07-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2017-01

**Status Verified Date:** 2019-09

#### Study First Post Date
**Date:** 2017-02-23
**Type:** ACTUAL
**Study First Submit Date:** 2017-01-25
**Study First Submit QC Date:** 2017-02-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Radboud University Medical Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This is a 12 week double-blind randomized placebo controlled trial in which 30 patients with very early SSc, fulfilling the Very Early Diagnosis Of Systemic Sclerosis (VEDOSS) criteria (9) will be randomized in a 2:1 fashion to receive intravenous methylprednisolone or placebo. Three-day treatment courses are given at week 0, week 4 and week 8. The final assessment is at week 12, and patients will be followed up to one year after baseline

**Detailed Description:** Systemic sclerosis is a disease with a high burden caused by morbidity and increased mortality. To date a cure for SSc is not available. In this trial, patients are treated very early in the disease which could change the long term outcome of SSc in these patients.

In daily practice, patients so early in the disease course are not treated although they might be at risk for early escalation and internal organ involvement, reducing their prognosis. A trial to investigate the efficacy of a relative save, inexpensive and easy accessible treatment will provide us with the opportunity to change the disease course and reducing the disease burden of a portion of the SSc patients

### Conditions Module

**Conditions:**

- Systemic Sclerosis

- Raynaud Phenomena

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- EARLY_PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** the methylprednisolone is dissolved in 100 cc of sodium chloride (NaCl 0.9%) by intravenous infusion in 30 minutes on three consecutive days

**Intervention Names:**

- Drug: Methylprednisolone

**Label:** Methylprednisolone 1000 mg

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** The placebo intervention with physiologic salt solution is identical in appearance

**Intervention Names:**

- Other: sodium chloride

**Label:** sodium chloride

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Methylprednisolone 1000 mg

**Description:** methylprednisolone 1000 mg dissolved in 100 cc of NaCl 0.9%, by intravenous infusion in 30 minutes on three consecutive days Three-day treatment courses are given at week 0, week 4 and week 8.

**Name:** Methylprednisolone

**Other Names:**

- Solu-Medrol

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- sodium chloride

**Description:** 100 cc of NaCl 0,9% , administered by intravenous infusion in 30 minutes on three consecutive days Three-day treatment courses are given at week 0, week 4 and week 8.

**Name:** sodium chloride

**Other Names:**

- NaCl 0,9%

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** presence of enlarged and giant capillaries, hemorrhages, loss of capillaries, disorganization of the micro vascular array, and capillary ramifications.

**Measure:** the change in capillary density from baseline

**Time Frame:** 12 weeks

#### Secondary Outcomes

**Description:** Plasma biomarkers consist soluble inflammatory mediators platelet factor 4, interleukin-1β, interleukin-6, tumor necrosis factor-α, endothelin-1, intercellular adhesion molecule-1 and vascular endothelial growth factor

**Measure:** change in selected biomarkers: the interferon signature in peripheral blood from baseline

**Time Frame:** 1 year

**Description:** changes in nail fold capillary pattern (early, active, late, normal

**Measure:** change in nail fold capillary changes other than capillary density and giant capillaries from baseline

**Time Frame:** 1 year

**Measure:** change in modified Rodnan skin score (mRSS) from baseline

**Time Frame:** 1 year

**Measure:** presence of puffy fingers from baseline

**Time Frame:** 1 year

**Measure:** presence of synovitis from baseline

**Time Frame:** 1 year

**Measure:** presence of tendon friction rubs from baseline

**Time Frame:** 1 year

**Measure:** fulfilling EULAR/ACR ( American College of Rheumatology )classification from baseline criteria for SSc from baseline

**Time Frame:** 1 year

**Measure:** pulmonary function tests from baseline

**Time Frame:** 1 year

**Measure:** presence of interstitial lung disease from baseline

**Time Frame:** 1 year

**Measure:** suspicion of pulmonary hypertension from baseline

**Time Frame:** 1 year

**Measure:** Change in physical function from baseline

**Time Frame:** 1 year

**Measure:** general health score from baseline

**Time Frame:** 1 year

**Measure:** Change in 36-Item Short Form Survey (SF-36) total score from baseline

**Time Frame:** 1 year

**Measure:** Change in Scleroderma Health Assessment Questionnaire (SHAQ)total score from baseline

**Time Frame:** 1 year

**Measure:** Change in EQ-5D is a standardised instrument for use as a measure of health outcome. (EQ5D) total score from baseline

**Time Frame:** 1 year

**Measure:** Change in gastrointestinal tract ( GIT ) total score from baseline

**Time Frame:** 1 year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Written informed consent
* Age over 18 years
* Fulfilling VEDOSS criteria (9):

  * Raynauds' Phenomenon and
  * Positive for disease specific auto antibodies (anti-centromere or anti-topoisomerase antibodies) and
  * typical nail fold capillaroscopic findings
* Puffy fingers \< 3 years
* Modified Rodnan skin score = 0

Exclusion Criteria:

* Presence of acroosclerosis, acrosteolysis and digital ulcers
* Presence of anti-RNA polymerase III auto antibodies

Previous systemic treatment for SSc, namely:

* methotrexate,
* prednisone (\> 14 days in previous 6 months),
* mofetil mycophenolate
* cyclophosphamide.

Clinically significant internal organ involvement:

* diffusion capacity of lung for carbon monoxide (DLCO) \< 80% predicted,
* vital capacity (VC) \< 70% predicted
* renal dysfunction with glomerular filtration rate (GFR) \< 60 ml/min
* diastolic dysfunction \> grade 1 on echocardiography
* pulmonary hypertension
* weight loss \>10% in the last 6 months with unknown cause

Contra-indications for methylprednisolone, such as:

* pregnancy, lactation
* psychotic or depressive disorder
* ulcus duodeni or ventriculi
* untreated hypertension (\> 160-90 mmHg)
* acute infections

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** sjoukje.mulder@radboudumc.nl

**Name:** Sjoukje Mulder

**Phone:** +31 24 3619398

**Role:** CONTACT

**Contact 2:**

**Name:** Brigit Kersten

**Phone:** +31 24 361 4580

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Nijmegen

**Contacts:**

***Contact 1:***

- **Email:** sjoukje.mulder@radboudumc.nl

- **Name:** Sjoukje Mulder

- **Phone:** +31 24 3619398

- **Role:** CONTACT

***Contact 2:***

- **Email:** B.Kersten@radboudumc.nl

- **Name:** Brigit Kersten

- **Role:** CONTACT

***Contact 3:***

- **Name:** Brigit Kersten

- **Role:** SUB_INVESTIGATOR

***Contact 4:***

- **Name:** Madelon Vonk

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Netherlands

**Facility:** Radboudumc, Rheumatology department

**State:** Gelderland

**Status:** RECRUITING

**Zip:** 6500 HB

#### Overall Officials

**Official 1:**

**Affiliation:** Radboud University Medical Center

**Name:** Madelon Vonk, Dr.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

### References Module

#### References

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## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000003240

- Term: Connective Tissue Diseases

- ID: D000012871

- Term: Skin Diseases

- ID: D000090122

- Term: Livedoid Vasculopathy

- ID: D000013927

- Term: Thrombosis

- ID: D000016769

- Term: Embolism and Thrombosis

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000016491

- Term: Peripheral Vascular Diseases

- ID: D000017445

- Term: Skin Diseases, Vascular

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M15415

- Name: Sclerosis

- Relevance: HIGH

- As Found: Sclerosis

- ID: M15412

- Name: Scleroderma, Systemic

- Relevance: HIGH

- As Found: Systemic Sclerosis

- ID: M25560

- Name: Scleroderma, Diffuse

- Relevance: HIGH

- As Found: Systemic Sclerosis

- ID: M14772

- Name: Raynaud Disease

- Relevance: HIGH

- As Found: Raynaud's Phenomenon

- ID: M6464

- Name: Connective Tissue Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2750

- Name: Livedoid Vasculopathy

- Relevance: LOW

- As Found: Unknown

- ID: M16686

- Name: Thrombosis

- Relevance: LOW

- As Found: Unknown

- ID: M7784

- Name: Embolism

- Relevance: LOW

- As Found: Unknown

- ID: M19128

- Name: Embolism and Thrombosis

- Relevance: LOW

- As Found: Unknown

- ID: M29213

- Name: Peripheral Arterial Disease

- Relevance: LOW

- As Found: Unknown

- ID: M18894

- Name: Peripheral Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M19714

- Name: Skin Diseases, Vascular

- Relevance: LOW

- As Found: Unknown

- ID: T5565

- Name: Systemic Scleroderma

- Relevance: HIGH

- As Found: Systemic Sclerosis

- ID: T3486

- Name: Livedoid Vasculopathy

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011928

- Term: Raynaud Disease

- ID: D000012595

- Term: Scleroderma, Systemic

- ID: D000045743

- Term: Scleroderma, Diffuse

- ID: D000012598

- Term: Sclerosis

### Intervention Browse Module - Ancestors

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000000932

- Term: Antiemetics

- ID: D000001337

- Term: Autonomic Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000005765

- Term: Gastrointestinal Agents

- ID: D000005938

- Term: Glucocorticoids

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000018696

- Term: Neuroprotective Agents

- ID: D000020011

- Term: Protective Agents

- ID: D000018931

- Term: Antineoplastic Agents, Hormonal

- ID: D000000970

- Term: Antineoplastic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: AnEm

- Name: Antiemetics

- Abbrev: NeuroAg

- Name: Neuroprotective Agents

- Abbrev: Gast

- Name: Gastrointestinal Agents

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M14120

- Name: Prednisolone

- Relevance: HIGH

- As Found: Smoking

- ID: M11749

- Name: Methylprednisolone

- Relevance: HIGH

- As Found: Smoking

- ID: M1833

- Name: Methylprednisolone Acetate

- Relevance: HIGH

- As Found: Smoking

- ID: M11750

- Name: Methylprednisolone Hemisuccinate

- Relevance: HIGH

- As Found: Erythropoietin

- ID: M229449

- Name: Prednisolone acetate

- Relevance: HIGH

- As Found: Smoking

- ID: M211887

- Name: Prednisolone hemisuccinate

- Relevance: HIGH

- As Found: Smoking

- ID: M248881

- Name: Prednisolone phosphate

- Relevance: HIGH

- As Found: Smoking

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4251

- Name: Antiemetics

- Relevance: LOW

- As Found: Unknown

- ID: M8881

- Name: Gastrointestinal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M9047

- Name: Glucocorticoids

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20773

- Name: Neuroprotective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M21869

- Name: Protective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20966

- Name: Antineoplastic Agents, Hormonal

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000008775

- Term: Methylprednisolone

- ID: D000077555

- Term: Methylprednisolone Acetate

- ID: D000008776

- Term: Methylprednisolone Hemisuccinate

- ID: D000011239

- Term: Prednisolone

- ID: C000009935

- Term: Prednisolone acetate

- ID: C000021322

- Term: Prednisolone hemisuccinate

- ID: C000009022

- Term: Prednisolone phosphate

### Misc Info Module

- Version Holder: 2024-05-24
