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Systemic Sclerosis-Associated PAHPhase 2NCT01086540

Rituximab for Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH)

A Phase 2 study testing Rituximab, CMRI and prednisone in people with Systemic Sclerosis-Associated PAH, run by National Institute of Allergy and Infectious Diseases (NIAID) at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Systemic sclerosis-associated pulmonary arterial hypertension (SSc-PAH) is a serious, life-threatening manifestation of systemic sclerosis (SSc), an autoimmune disease of the connective tissue characterized by scarring (fibrosis) and atrophy of the skin, joints and tendons, skeletal muscles, and internal organs, and… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Systemic Sclerosis-Associated PAH
What is being tested?
Rituximab, CMRI and prednisone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
57 participants
Where
17 sitesUnited States
Study dates
24 Jun 2011to 15 Dec 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject has provided written informed consent.
  • Clinical diagnosis of systemic sclerosis (either limited or diffuse cutaneous disease).
  • Diagnosis of SSc-PAH within the past 5 years, with a mean pulmonary arterial pressure of ≥ 25 mmHg at entry.
  • Mean Pulmonary Vascular Resistance (PVR) of > 3 Wood units.
  • Screening 6-minute Walking Distance (6MWD) of at least 100 meters.
  • New York Heart Association (NYHA) Functional Class II, III, or IV.
Show all 10Show fewer
  • Subject must be able to maintain O2 saturation ≥ 90% at rest (with or without oxygen);
  • --Oxygen use is permitted.
  • Subject must be vaccinated with the pneumococcal vaccine at least one month prior to initiation of therapy, unless subject was vaccinated within 5 years of study entry.
  • Subject must have been treated with background medical therapy for PAH (prostanoid, endothelin receptor antagonist, PDE-5 inhibitor, and/or guanylate cyclase stimulators) for a minimum of 8 weeks and have been on stable dose medical therapy for at least 4 weeks prior to randomization with no expectation of change for 24 weeks after randomization.

Who cannot join

  • Documented PAH for greater than 5 years at the time of randomization defined as:
  • Measurement of a mean Pulmonary Artery Pressure (PAP) > 25 mmHg by right heart catheterization at least 5 years previously, OR
  • Treatment with targeted background PAH therapy for > 5 years.
  • Pulmonary Capillary Wedge Pressure > 15 mmHg or Left Ventricular End Diastolic Pressure > 15 mmHg.
  • Persistent hypotension with Systolic Blood Pressure (SBP) < 90 mmHg.
  • Treatment with cyclophosphamide within 4 weeks of randomization.
Show all 32Show fewer
  • Treatment with immunocompromising biologic agents within 4 weeks prior to treatment initiation or treatment with infliximab within 8 weeks prior to treatment initiation.
  • If being treated with a non-biologic immunosuppressive or immunomodulating drug, changes in dosage within 4 weeks prior to randomization. Subjects taking prednisone or equivalent corticosteroid > 10mg daily are excluded.
  • Previous exposure to any lymphocyte or B cell depleting agent.
  • PAH for any reason other than SSc.
  • History of coronary artery disease, significant ventricular tachy-arrhythmia, stent placement, coronary artery bypass surgery, and/or myocardial infarction.
  • Moderate or severe interstitial lung disease.
  • Chronic infections.
  • Positive serology for infection with hepatitis B or C.
  • A deep space infection within the past 2 years.
  • Evidence of active infection within 2 weeks of randomization
  • Presence of a positive tuberculosis (TB) skin test (e.g., PPD test) or positive QuantiFERON®-TB blood test, an indeterminate QuantiFERON®-TB blood test, or latent tuberculosis (TB).
  • Significant renal insufficiency.
  • Active, untreated SSc renal crisis at the time of enrollment.
  • Recent administration of a live vaccine (< 8 weeks) or any other immunization within 4 weeks of treatment.
  • History of anaphylaxis or Immunoglobulin E (IgE) -mediated hypersensitivity to murine proteins or any component of rituximab.
  • Pregnancy.
  • Lactation.
  • History of malignancy within the last 5 years, except for resected basal or squamous cell carcinoma, treated cervical dysplasia, or treated in situ cervical cancer Grade I.
  • A woman of childbearing potential who is unwilling to use a medically acceptable form of birth control
  • History of non-compliance with other medical therapies.
  • History of alcohol or drug abuse within 1 year of randomization.
  • Receipt of any investigational drug or device within 4 weeks before the Screening Visit, with the exception of investigational prostanoids, endothelin receptor antagonists, and PDE-5 inhibitors, and guanylate cyclase stimulators.
  • Recipient of lung transplant.
  • Laboratory parameters at the screening visit showing any of the following abnormal results: Transaminases > 2x the upper limit of normal (ULN) and/or bilirubin > 2x ULN; Absolute neutrophil count < 1,500/mm^3; Platelet count < 100,000/mm^3; Hemoglobin < 9 g/dL.
  • Concurrent treatment in a clinical research study using a non-FDA approved agent with the exception of an open-label study/study extension of investigational prostanoids, endothelin receptor antagonists, and PDE-5 inhibitors, and guanylate cyclase stimulators, provided the open-label investigational drug will be available and dose will remain stable through the trial's primary outcome time point of 24 weeks after randomization in this study, ASC01 (NCT01086540).
  • Any condition or treatment, which in the opinion of the investigator, places the subject at unacceptable risk as a participant in the trial.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • University of Colorado Health Sciences Center

    Aurora, Colorado, 80045

  • Johns Hopkins University, Pulmonary and Critical Care Medicine

    Baltimore, Maryland, 21205

  • Boston University Medical Center

    Boston, Massachusetts, 02118

  • University of North Carolina at Chapel Hill: UNC Hospitals

    Chapel Hill, North Carolina, 27514

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Ohio State University

    Columbus, Ohio, 43210

  • University of Texas Southwestern Medical Center-William P. Clements University Hospital

    Dallas, Texas, 75390

  • University of Texas: Memorial Herman Hospital

    Houston, Texas, 77030

  • University of Iowa

    Iowa City, Iowa, 52242

  • University of Minnesota Health Clinics and Surgery Center

    Minneapolis, Minnesota, 55455

  • Columbia University Medical Center

    New York, New York, 10032

  • Weill Cornell Medical College

    New York, New York, 10065

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15261

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • University of Utah

    Salt Lake City, Utah, 84132

  • Stanford Health Care

    Stanford, California, 94305

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase II Multicenter Trial of a Monoclonal Antibody to CD20 (Rituximab) for the Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH)

Systemic sclerosis-associated pulmonary arterial hypertension (SSc-PAH) is a serious, life-threatening manifestation of systemic sclerosis (SSc), an autoimmune disease of the connective tissue characterized by scarring (fibrosis) and atrophy of the skin, joints and tendons, skeletal muscles, and internal organs, and immunological disturbances. One-year survival for patients with SSc-PAH ranges from 50-81%. There is currently no cure for SSc-PAH and treatment is limited to vasodilator therapy used in all forms of PAH. In recent studies, immunotherapy was shown to be effective in treating SSc-interstitial lung disease, another serious, life-threatening manifestation of SSc. In addition, there are compelling pre-clinical data and anecdotal clinical reports that suggest modulation of the immune system may be an effective strategy for treating SSc-PAH. To test this approach, this trial will determine if rituximab, an immunotherapy, has a marked beneficial effect on clinical disease progression, with minimal toxicity, in patients with SSc-PAH when compared to placebo.

Read the detailed description

This prospective, double-blind, placebo-controlled, multi-center, randomized trial will evaluate the effect of rituximab on disease progression in subjects with SSc-PAH receiving concurrent stable-dose standard medical therapy with a prostanoid, endothelin receptor antagonist, and/or phosphodiesterase 5 (PDE-5) inhibitor. The study will focus on assessment of clinical response and safety measures longitudinally. In addition, the effects of treatment with rituximab on the underlying immune mechanisms associated with B-cell dysregulation and pathogenic autoantibody response in this disease will be investigated. 1000 mg of rituximab or placebo will be administered as two IV infusions given two weeks apart. Clinical assessments and sample collection will occur at monthly visits through Week 48. If a participant has not recovered B cells by Week 48, B cell studies will be conducted quarterly until reconstitution is documented or for 2 years after initial treatment.

This trial will include a sub-study, entitled "Right Ventricular Response to Rituximab in Systemic Sclerosis-Associated Pulmonary Arterial Hypertension - A Magnetic Resonance Imaging Sub-study" (RESTORE Sub-study). The objective of the RESTORE sub-study is to evaluate the therapeutic effect of rituximab on the right ventricle of patients with SSc-PAH. Changes in right ventricular end diastolic volume index (RVEDVI) and stroke volume (SV) determined by cardiac MRI will be used as surrogates of right ventricle function and prognosis. Enrollment for the RESTORE sub-study will parallel that of main trial. Twenty patients from each treatment arm, distributed among all participating sites, will be recruited for this sub-study. Each patient will be studied at baseline (i.e. prior to initiation of study drug) and after 24 weeks or at time of discontinuation. In addition to the data collection and testing specified in the main trial, participants in RESTORE will undergo comprehensive cardiac MRI evaluation. All main trial study inclusion and exclusion criteria apply, as well as additional exclusion criteria that pertain only to the RESTORE sub-study: 1) known hypersensitivity to Gadolinium; 2) inability to tolerate or cooperate with MRI; 3) morbid obesity; and 4) presence of metallic objects or pacemakers.

Being tested
Rituximab, Placebo, CMRI, prednisone, methylprednisolone
Keywords
Pulmonary Arterial Hypertension (PAH), Autoimmune Disease, Systemic Scleroderma
Medical subject headings
Pulmonary Arterial Hypertension, Autoimmune Diseases, Scleroderma, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RituximabBiological

    Also called Rituxan®

    Participants receive rituximab intravenous (IV) infusions, 1000 mg each, 14 days apart (Day 0 and Week 2).

    Rituximab is supplied as a sterile, clear, colorless, preservative-free liquid concentrate for intravenous (IV) administration in either 100 mg (10 mL) or 500 mg (50 mL) single-use vials, which must be diluted before administration

    Standard rituximab pre-medications will be provided in preparation for the rituximab infusions.

  • PlaceboOther

    Also called Placebo for rituximab

    Participants receive placebo intravenous (IV) infusions 14 days apart (Day 0 and Week 2).

    Standard pre-medications will be provided in preparation for the infusions.

  • CMRIDiagnostic test

    Also called cardiac MRI, cardiac Magnetic Resonance Imaging

    Up to 20 participants from each treatment arm will be assessed by CMRI at Baseline and at Week 24.

  • prednisoneDrug

    Also called prednisone tablets, Rayos®

    Prednisone dose of 40 mg (or equivalent) by mouth administered the night before and the morning of each study drug infusion.

  • methylprednisoloneDrug

    Also called corticosteroid

    Methylprednisolone (or equivalent corticosteroid) administered intravenously 30 minutes prior to each study drug infusion.

  • diphenhydramineDrug

    Also called Benadryl®

    Diphenhydramine 50 mg (or equivalent) administered by mouth approximately thirty to sixty minutes prior to each study drug infusion.

    Dose may be repeated every four hours, as needed.

  • acetaminophenDrug

    Also called Tylenol®

    Acetaminophen 650 mg (or equivalent) administered by mouth approximately thirty to sixty minutes prior to each study drug infusion.

    Dose may be repeated every four hours, as needed.

Study groups in NCT01086540
Study groupRoleWhat they receive
Rituximab+PAH SOCExperimentalRituximab (1000 mg) will be administered as 2 intravenous infusions given 2 weeks apart. Concurrent stable-dose Pulmonary Arterial Hypertension (PAH) medical therapy will be continued/managed as per standard of care (PAH SOC).
Receives: Biological: Rituximab; Diagnostic Test: CMRI; Drug: prednisone; Drug: methylprednisolone; Drug: diphenhydramine; Drug: acetaminophen
Placebo + PAH SOCPlacebo comparatorPlacebo will be administered as 2 intravenous infusions given 2 weeks apart. Concurrent stable-dose Pulmonary Arterial Hypertension (PAH) medical therapy will be continued/managed as per standard of care (PAH SOC).
Receives: Other: Placebo; Diagnostic Test: CMRI; Drug: prednisone; Drug: methylprednisolone; Drug: diphenhydramine; Drug: acetaminophen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Distance Walked During a Six Minute Walk Test

    The six minute walk test measures the distance a participant is able to walk over a total of six minutes on a hard, flat surface. The goal is for the participant to walk as far as possible in six minutes. The participant is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. The total distance walked, in meters, was recorded for each participant. Longer distances indicate better outcomes.

    Measured: Baseline (Pre Treatment Initiation) to Week 24

Secondary outcomes (18)

  1. Change From Baseline in Pulmonary Vascular Resistance Measured by Right Heart Catheterization at Week 24

    During a right heart catheterization, a catheter is guided to the right side of the heart and then into the pulmonary artery; blood flow through the heart is observed and is used to measure pressures in a participant's heart and lungs. The calculation of Pulmonary Vascular Resistance (PVR) is measured in Woods Units. Change is derived by measuring the difference between Baseline and Week 24 PVR (Week 24 minus Baseline). Higher PVR values indicate worse disease status.

    Measured: Baseline (Pre Treatment Initiation) to Week 24

  2. Change From Baseline in Distance Walked During a Six Minute Walk Test at Week 24 and Week 48

    The six minute walk test measures the distance a participant is able to walk over a total of six minutes on a hard, flat surface. The goal is for the participant to walk as far as possible in six minutes. The participant is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. The total distance walked, in meters, was recorded for each participant. Longer distances indicate better outcomes.

    Measured: Baseline (Pre Treatment Initiation) to Week 24 and Week 48

  3. Time to Clinical Worsening

    Assessment of time to clinical worsening, censored at Week 48, defined as the first occurrence of any of the following:

    • death,
    • hospitalization for Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH),
    • lung transplantation,
    • atrial septostomy,
    • addition of other Pulmonary Arterial Hypertension (PAH) therapeutic agents, or
    • worsening of the six minute walk distance by > 20% and an increase in New York Heart Association functional class.

    Time to clinical worsening was defined as the first date that met any of the above criteria and was calculated in study days as: date of first event minus (-) date of treatment randomization. If a participant did not experience any of the referenced events by Week 48 or, if the date of death was after the 48 week follow-up period, time to clinical worsening was equal to the participant's duration of follow-up in the study.

    Measured: Baseline (Pre Treatment Initiation) to Week 48

  4. Time to the Change or Addition of New Pulmonary Arterial Hypertension (PAH) Therapeutic Medications

    Per protocol, from the time of study entry, participants were to remain on background PAH medical therapy with either a single agent or a combination of prostanoid, endothelin receptor antagonist, PDE-5 inhibitor, and/or guanylate cyclase stimulators as per the entry criteria. Doses should have remained stable through the Week 24 primary outcome/endpoint visit. If a dose of a background PAH medication was changed or a new PAH medication was added during the course of the trial, the date of the first dose change or additional medication was recorded. Time to the addition or modification of PAH medications was defined in study days as: date of the first time a PAH medication was modified or added minus (-) date of randomization.

    Measured: Baseline (Pre Treatment Initiation) to Week 48

  5. Change From Baseline in Quality of Life as Measured by the Short Form Health Survey (SF-36): Mental Component Summary Score

    The SF-36 measures health-related quality of life. It has 36 items and 2 component scores, the Physical Component Score and the Mental Component Score. The SF-36 Mental Health component summary score is comprised of the Vitality Scale, the Social Functioning Scale, the Role-Emotional Scale, and the Mental Health Scale. It is scaled from 0 to 100 with a score of 0 equivalent to maximum disability and a score of 100 is equivalent to no disability. A negative value indicates a decrease in quality of life from Baseline.

    Measured: Baseline (Pre Treatment Initiation) to Week 24 and Week 48

  6. Change From Baseline in Quality of Life as Measured by the Short Form Health Survey (SF-36): Physical Component Summary Score

    The SF-36 measures health-related quality of life. It has 36 items and 2 component scores, the Physical Component Score and the Mental Component Score. The SF-36 Physical component summary score is comprised of the Physical Functioning Scale, the Role-Physical Scale, the Bodily Pain Scale, and the General Health Scale. It is scaled from 0 to 100 with a score of 0 equivalent to maximum disability and a score of 100 is equivalent to no disability. A negative value indicates a decrease in quality of life from Baseline.

    Measured: Baseline (Pre Treatment Initiation) to Week 48

  7. Change in Quality of Life as Measured by the Disability Index of the Scleroderma Health Assessment Questionnaire (HAQ-DI)

    The HAQ-DI is a self-reported questionnaire of functionality that includes questions in 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities) and addresses scleroderma related manifestations that contribute to disability. The final score ranges from 0 to 3, where a higher HAQ-DI score indicates a worse outcome.

    Measured: Baseline (Pre Treatment Initiation) to Week 24 and Week 48

  8. Number of New Digital Ulcers

    The total number of digital ulcers present on the dorsal and palmar surfaces for both the left and right fingers were captured at the Baseline study visit. The number of new digital ulcers since the last study visit (including any ulcers that had appeared and healed since the last study visit) on the dorsal and palmar surfaces for both the left and right fingers were captured at the post-Baseline study visits. The total number of digital ulcers on both hands was summed from the number present on the dorsal and palmar surfaces for both the left and right fingers.

    Measured: Baseline (Pre Treatment Initiation) to Week 24 and Week 48

  9. Change in Severity of Raynaud's Phenomenon

    Severity of Raynaud's phenomenon was measured by a Visual Analog Scale (VAS) of the Scleroderma Health Assessment Questionnaire (SHAQ). The SHAQ VAS includes a question asking, "In the past week, how much has your Raynaud's Phenomenon interfered with your activities?" Participants were asked to place a mark on a 15 cm line, scaled from 0 (does not interfere) to 100 (very severe limitation), to describe the severity of their Raynaud's phenomenon in the past week. The distance from the left edge of the line to the vertical line placed by the participant was measured in centimeters; VAS scores were converted to a 0 to 100 scale.

    Measured: Baseline (Pre Treatment Initiation) to Week 24 and Week 48

  10. Change in Carbon Monoxide Diffusing Capacity (DLCO)

    Carbon Monoxide Diffusing Capacity (DLCO) is a measure of lung function. Predicted values for DLCO were computed according to the Global Lung Function Initiative (GLI) all-age reference values and corrected for hemoglobin. Lower DLCO values indicate worse disease activity.

    DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide)

    Measured: Baseline (Pre Treatment Initiation) to Week 24 and Week 48

  11. Oxygen Saturation Levels at Week 24 and Week 48

    Oxygen saturation is the amount of oxygen that is in your bloodstream and is measured as the percentage of blood hemoglobin that is carrying oxygen. Normal oxygen saturation levels are considered to be 95-100 percent; low oxygen saturation values indicate worse disease. Room air oxygen saturation by pulse oximetry and/or amount of supplemental oxygen used, if saturation <90%, were recorded.

    Measured: Week 24 , Week 48

  12. Percent Change From Baseline in Pulmonary Vascular Resistance Measured by Right Heart Catheterization

    During a right heart catheterization, a catheter is guided to the right side of the heart and then into the pulmonary artery; blood flow through the heart is observed and is used to measure pressures in a participant's heart and lungs. Pulmonary vascular resistance (PVR) is measured in Woods Units. Higher PVR values indicate worse disease status.

    Change in PVR is determined by Baseline value minus (-) Week 24 value.

    Measured: Baseline (Pre Treatment Initiation) to Week 24

  13. Number of Infusion-Related Toxicities

    The number of Grade 3, 4, and 5 Adverse Events (AEs), which were defined as possibly, probably, or definitely related to rituximab or placebo infusion.

    This study graded the severity of adverse events according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0.

    Measured: Day 0 (Treatment Randomization) to Week 48

  14. Number of Grade 3 or Higher Adverse Events (AEs) Through Week 48

    Total number of Grade 3, 4, and 5 AEs. Ref: National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0.

    Measured: Baseline (Pre Treatment Initiation) to Week 48

  15. Number of Infection-Related Adverse Events (AEs) Through Week 48

    Number of adverse events classified as infections. Reference: National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0.

    Measured: Day 0 (Treatment Randomization) to Week 48

  16. Treatment-Related Mortality: From Treatment Initiation to Week 48

    Death occurring after randomization and ≤ Week 48, and possibly, probably, or definitely resulting from assigned study treatment.

    Measured: Day 0 (Treatment Randomization) to Week 48

  17. All-Cause Mortality: From Treatment Initiation to Week 48

    Death from any cause occurring after randomization and ≤ Week 48.

    Measured: Day 0 (Treatment Randomization) to Week 48

  18. All-Cause Mortality: From Treatment Initiation to Week 104

    Death from any cause occurring after randomization and ≤ Week 104.

    Measured: Day 0 (Treatment Randomization) to Week 104

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2010 (estimated)
  2. Study start24 Jun 2011
  3. Primary completion5 Jun 2018
  4. Study completion15 Dec 2019

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01086540
Sponsor's protocol ID
DAIT ASC01
Status last verified
Jan 2023
First submitted
11 Mar 2010
Last updated
21 Feb 2023
Data monitoring committee
Yes

Publications

  • Zamanian RT, Badesch D, Chung L, Domsic RT, Medsger T, Pinckney A, Keyes-Elstein L, D'Aveta C, Spychala M, White RJ, Hassoun PM, Torres F, Sweatt AJ, Molitor JA, Khanna D, Maecker H, Welch B, Goldmuntz E, Nicolls MR. Safety and Efficacy of B-Cell Depletion with Rituximab for the Treatment of Systemic Sclerosis-associated Pulmonary Arterial Hypertension: A Multicenter, Double-Blind, Randomized, Placebo-controlled Trial. Am J Respir Crit Care Med. 2021 Jul 15;204(2):209-221. doi: 10.1164/rccm.202009-3481OC.

    PubMed 33651671

  • Zhang Y, Michelakis ED. A Phase-2 NIH-sponsored Randomized Clinical Trial of Rituximab in Scleroderma-associated Pulmonary Arterial Hypertension Did Not Reach Significance for Its Endpoints: End of Story? Not So Fast! Am J Respir Crit Care Med. 2021 Jul 15;204(2):123-125. doi: 10.1164/rccm.202103-0612ED. No abstract available.

    PubMed 33856964

  • Andreasson K, Bengtsson MF, Bostrom C, Hesselstrand R, Volkmann ER. Multiple Manifestations of Systemic Sclerosis Affect Walk Distance. Am J Respir Crit Care Med. 2021 Aug 1;204(3):359. doi: 10.1164/rccm.202104-0938LE. No abstract available.

    PubMed 34107236

  • Zamanian RT, Pinckney A, Domsic RT, Medsger T, Keyes-Elstein L, Sweatt AJ, Welch B, Goldmuntz E, Nicolls MR, Chung L. Reply to Andreasson et al.: Multiple Manifestations of Systemic Sclerosis Affect Walk Distance. Am J Respir Crit Care Med. 2021 Aug 1;204(3):377-378. doi: 10.1164/rccm.202104-1023LE. No abstract available.

    PubMed 34107229

  • de Bourcy CFA, Dekker CL, Davis MM, Nicolls MR, Quake SR. Dynamics of the human antibody repertoire after B cell depletion in systemic sclerosis. Sci Immunol. 2017 Sep 29;2(15):eaan8289. doi: 10.1126/sciimmunol.aan8289.

    PubMed 28963118

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rituximab, CMRI and prednisone in people with Systemic Sclerosis-Associated PAH, run by National Institute of Allergy and Infectious Diseases (NIAID) at 17 sites in United States.

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 10 inclusion and 32 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 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. 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 21 Aug 2020). 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 Distance Walked During a Six Minute Walk Test (time frame: Baseline (Pre Treatment Initiation) to 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 NCT01086540, which also lists 5 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 21 Feb 2023.

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