Is NCT03630211 recruiting in Pittsburgh, PA?

Yes, NCT03630211 is currently recruiting participants at its Pittsburgh, PA location. This systemic sclerosis clinical trial is actively enrolling qualified participants.

How do I join the systemic sclerosis clinical trial in Pittsburgh?

To join this clinical trial in Pittsburgh, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Pittsburgh clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Systemic Sclerosis Clinical Trial in Pittsburgh, PA

Who Can Participate

Inclusion Criteria

Individuals must meet all the following criteria to be eligible for this study.

Patient, parent, or legal guardian must have given written informed consent. For patients ≥ 168 years of age who are developmentally able, assent or affirmation will be obtained.

Age 8-24, inclusive, at time of consent.

Diagnosed with Systemic Sclerosis (SSc) at the age of ≤19.

Failure to respond, specifically no improvement or progression of disease, to at least 2 disease-modifying antirheumatic drugs (DMARDS) within 12 months of consent with any of the following conditions:

Progression of skin thickening over the past 6 months or Modified Rodnan skin score (mRSS) ≥ 20

Progression of ILD within 18 months prior to consent. Progression to be determined by either of the following:

CT scan showing increased ground glass opacities or reticulations OR

Pulmonary function testing (PFTs) showing a decrease in FVC% or DLCO% predicted value of ≥10%.

Myositis - CPK \> 2x upper limit of normal or MRI consistent with myositis

Childhood Myositis Assessment Score \< 30

Digital tip ulcerations

Cardiology clearance to undergo stem cell transplantation (documented in subject's medical chart)

Negative for human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, all confirmed by PCR testing.

Negative pregnancy test for females. who have reached menarche. 87\. All females of childbearing potential and sexually active males must agree to use an FDA approved method of birth control for up to 24 months after BMT or for as long as they are taking any medication that may harm a pregnancy, an unborn child or may cause a birth defect.

Exclusion Criteria

Individuals who meet any of these criteria are not eligible for this study.

FVC \<35%, determined by pulmonary function tests for those able to complete spirometry adequately (per investigator's determination)

O2 sat \<92% at rest in room air

Estimated CrCl \<40 mL/min,using Cockcroft-Gault formula based on actual body weight.

Active, untreated SSc renal crisis at the time of consent.

ALT \> 4x upper limit of normal.

Active, uncontrolled infection that would be a contraindication to safe use of high-dose immunosuppressive therapy or cyclophosphamide.

Hematologic abnormalities as defined by any of the following peripheral blood counts:

ANC \< 1500 cell/µL.

Platelets \< 100,000 cells/ µL.

Hemoglobin \< 9.0 g/dL.

Malignancy within 2 years prior to enrollment, excluding adequately treated squamous cell cancer, basal cell carcinoma or carcinoma in situ. Treatment should have been completed with cure/remission status documented for at least 2 years.

Past or current medical problems or findings from medical history, physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study. Cohort 2 for Adults Inclusion: Individuals must meet all the following criteria to be eligible for this study.

Patient, parent, or legal guardian must have given written informed consent. For patients ≥ 16 years of age who are developmentally able, assent or affirmation will be obtained.

Age 1618-705560, inclusive, at time of consent. Patients up to age 24, diagnosed with SSc at age ≤ 19, will be included in Cohort 1 and evaluated according to the Pediatric and Young Adult criteria listed in sections 3.1.1 and 3.1.2.

Diagnosed with Systemic Sclerosis (SSc), according to the 2013 ACR/EULAR criteria (van den Hoogen et al., 2013).

All patients must meet either the following skin or ILD criteria. Disease duration is defined as time from first non-Raynaud symptom. Skin Criteria: Diffuse SSc, defined by presence of proximal skin thickening and: A. If disease duration is of \<2 years, patients must have a calculated mortality risk prediction score which places them in the intermediate or high- risk category (Domsic et al., 2016). Refer to Appendix 5 for calculation criteria. B. If disease duration is of \>2 years, patients must have evidence of active cutaneous disease based upon 1) a worsening Modified Rodnan Skin Score (MRSS) in the preceding three months or 2) the presence of palpable tendon friction rubs. ILD Criteria: A. The presence of recognized fibrosis on imaging of \<2 years AND either \> 10% of lung involvement by CT scan or FVC% pred \<80% or B. Fibrosis on imaging of any duration with a decline in FVC% pred of ≥10% over the preceding 12-18 months.

Negative for human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, all confirmed by PCR testing.

Negative pregnancy test for females.

All females of childbearing potential and sexually active males must agree to use an FDA approved method of birth control for up to 24 months after BMT or for as long as they are taking any medication that may harm a pregnancy, an unborn child or may cause a birth defect. Exclusion Criteria Individuals who meet any of these criteria are not eligible for this study.

Moderate to severe cardiac involvement defined by any of the following:

New York Heart Association classification of heart failure ≥3.

Left ventricular ejection fraction (LVEF) \<50% as determined by cardiac MRI.

Significant pulmonary hypertension, for subjects ≥ 18 years of age, defined as mean PASP ≥30 mmHg determined by right heart catheterization, or for subjects ≤ 17 years of age, defined as mean PASP \>45 mmHg, determined by echocardiogram.

Atrial tachycardia, atrial fibrillation or atrial flutter of ≥1-minute duration, determined by electrocardiogram (EKG) or, cardiac event monitor and/or implanted loop recorder (if applicable), or on anti-arrhythmic therapy for the arrhythmias listed above.

Ventricular tachycardia of ≥6 beats at rate of ≥100 beats per minute, determined by EKG or, cardiac event monitor and/or implanted loop recorder (if applicable), or on an anti-arrhythmic therapy for any ventricular arrhythmia.

Left bundle branch block, bifascicular heart block, Mobitz 2 heart block, complete heart block or infarction pattern as determined by EKG or, cardiac event monitor and/or implanted loop recorder

Presence of pacemaker or implantable cardioverter defibrillator.

Moderate to severe pulmonary involvement defined by any of the following:

Hemoglobin-corrected DLCO \<45%, determined by pulmonary function tests.

FVC \<45%, determined by pulmonary function tests.

pO2 \<70 mmHg, determined by an arterial blood gas (not applicable for subjects ≤17 years of age).

pCO2 ≥45 without supplemental O2 determined by an arterial blood gas (not applicable for subjects ≤17 years of age).

O2 sat \<92% at rest without supplemental O2, determined by an arterial blood gas (not applicable for subjects ≤17 years of age).

Six-minute walk (6MW) results \<400 feet.

Steroid therapy defined by either of the following:

Subjects who received \> 10 mg/day prednisone or equivalent within 30 days prior to start of conditioning regimen on Day -21.

Subjects who have been treated for concurrent illnesses (eg, asthma) with the equivalent of prednisone 1 mg/kg/day or its equivalent for \> 5 days on \> 2 occasions during the previous 12 months (prior to conditioning) or \> 1 occasion in the prior 6 months (prior to conditioning).

Estimated CrCl \<40 mL/min,using Cockcroft-Gault formula based on actual body weight.

Serum creatinine \>2.0 mg/dL.

Active, untreated SSc renal crisis at the time of consent.

Dependence on nutritional supplementation/hyperalimentation.

Active gastric antral vascular ectasia (GAVE), defined by a decrease in hemoglobin greater than 1 g/dL in the preceding 60 days, attributed to GAVE.

Active hepatitis defined by any of the following:

AST \> 2x upper limit of normal.

ALT \> 2x upper limit of normal.

Bilirubin \>2x upper limit of normal.

Evidence of moderate to severe periportal fibrosis, determined by liver biopsy, if applicable.

Active, uncontrolled infection that would be a contraindication to safe use of high-dose immunosuppressive therapy or cyclophosphamide.

Hematologic abnormalities as defined by any of the following peripheral blood counts:

ANC \< 1500 cell/µL.

Platelets \< 100,000 cells/ µL.

Hemoglobin \< 9.0 g/dL.

Evidence of myelodysplasia (MDS), confirmed by bone marrow aspirate, if applicable.

Females who are pregnant or who are lactating.

Tobacco use, by subject admission, within previous 4 weeks of time of consent.

History of sensitivity to murine proteins or E. coli proteins.

Known history of substance abuse, determined by medical record or subject admission, within 6 months of time of consent.

Patient with systemic reaction to anti-thymocyte globulin or any other equine gamma globulin preparation

Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Pittsburgh?

Yes, this clinical trial (NCT03630211) has an active research site in Pittsburgh, PA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Systemic Sclerosis Treatment Options in Pittsburgh, PA

If you're searching for systemic sclerosis treatment options in Pittsburgh, PA, this clinical trial (NCT03630211) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Pittsburgh research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced systemic sclerosis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all systemic sclerosis clinical trials near you to find additional studies recruiting in your area.

Systemic Sclerosis Clinical Trial in Pittsburgh, PA

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