Belimumab for the Treatment of Diffuse Cutaneous Systemic Sclerosis

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Brief Title

Belimumab for the Treatment of Diffuse Cutaneous Systemic Sclerosis

Official Title

Belimumab for the Treatment of Diffuse Cutaneous Systemic Sclerosis: A Phase 2a, Single-centered, Randomized, Placebo-controlled, Double-blind, Proof-of-concept Pilot Study.

Brief Summary

      This is a 48 week, phase IIa, single center, randomized, double-blind, placebo-controlled,
      proof-of-concept pilot study. All participants will first be treated with mycophenolate
      mofetil (MMF, Cellcept) and titrated up to a dose of 2 grams/day. Following this period, half
      will be given either a belimumab (Benlysta®) or placebo intravenous infusion to treat early
      diffuse cutaneous systemic sclerosis. Belimumab/MMF is expected to improve disease activity
      measured by an improvement in skin thickening and stability of pulmonary function test
      measurements when compared to patients treated with placebo/MMF.
    

Detailed Description

      The specific objectives of this study are to:

        1. Determine whether belimumab used in combination with MMF is safe and tolerable in the
           treatment of patients with early diffuse cutaneous systemic sclerosis (Disease duration
           < 3 years).

        2. Determine whether belimumab used in combination with MMF is more effective in the
           treatment of diffuse cutaneous systemic sclerosis than MMF alone, as measured by change
           in modified Rodnan Skin Score (mRSS), forced vital capacity (FVC), hemoglobin corrected
           diffusion capacity (DLCO), Medsger Severity Scale (MSS), and by other physician and
           patient derived outcome measures.

        3. Determine the biological activity of Belimumab/MMF as assessed by effect on histology of
           skin, change in B-Cell profiles, effect on BLyS levels, and effect on serological and
           cutaneous biomarkers of disease activity.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Change in Modified Rodnan Skin Score

Secondary Outcome

 Change in Pulmonary Function Test Measures

Condition

Systemic Sclerosis

Intervention

Belimumab

Study Arms / Comparison Groups

 Mycophenolate mofetil + Belimumab
Description:  All patients who enroll in this trial will FIRST receive mycophenolate mofetil (MMF, Cellcept), which is a drug commonly given to patients with scleroderma in clinical practice. This drug will be given at no cost to the patient. After the patient has been titrated to 2 grams of MMF per day, the patient will receive EITHER a 10 mg/kg belimumab (Benlysta) intravenous infusion OR a placebo (saline) infusion. This medication and infusion will of course be covered by the study.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

20

Start Date

August 2012

Completion Date

February 2016

Primary Completion Date

November 2015

Eligibility Criteria

        Inclusion Criteria:

          1. Age greater than or equal to eighteen years.

          2. Clinical diagnosis of diffuse systemic sclerosis by ACR criteria, with a stable
             modified Rodnan skin score in the one month preceding introduction of belimumab
             therapy.

          3. Disease duration of less than or equal to 3 years as defined by the date of onset of
             the first non-Raynaud's symptom.

        Exclusion Criteria:

          1. Inability to render informed consent in accordance with institutional guidelines.

          2. Disease duration of greater than 3 years.

          3. Patients with mixed connective tissue disease or "overlap" (i.e. those who satisfy
             more than one set of ACR criteria for a rheumatic disease.)

          4. Limited scleroderma.

          5. Systemic sclerosis-like illness associated with environmental or ingested agents such
             as toxic rapeseed oil, vinyl chloride, or bleomycin.

          6. Ongoing treatment with immunosuppressive therapies including cyclophosphamide,
             azathioprine, methotrexate, or cyclosporine, or use of those medications within 1
             month of trial entry.

          7. The use of other anti-fibrotic agents including colchicine, D-penicillamine,
             minocycline, tyrosine kinase inhibitors (nilotinib, imatinib, dasatinib), or Type 1
             oral Collagen in the month prior to enrollment.

          8. Use in the prior month of corticosteroids at doses exceeding the equivalent of
             prednisone 10 mg daily. Use of corticosteroid at < 10 mg of prednisone can continue
             during the course of the study.

          9. Treatment with MMF at a dose of ≥ 2 grams daily for > 3 months.

         10. Concurrent serious medical condition which in the opinion of the investigator makes
             the patient inappropriate for this study such as uncontrollable CHF, arrhythmia,
             severe pulmonary or systemic hypertension, severe GI involvement, hepatic impairment,
             serum creatinine of greater than 2.0, active infection, severe diabetes, unstable
             atherosclerotic cardiovascular disease, malignancy, HIV, or severe peripheral vascular
             disease.

         11. A positive pregnancy test at entry into this study.

         12. Men and women with reproductive potential will be required to use effective means of
             contraception through the course of the study, such as a tubal ligation or
             hysterectomy, condom or diaphragm used with a spermicide,or an intrauterine device
             (IUD). Approved hormonal contraceptives (such as birth control pills, patches,
             implants or injections) may interact with and reduce the effectiveness of MMF and
             thus, are not acceptable. Contraceptive measures such as Plan B (TM), sold for
             emergency use after unprotected sex, are not acceptable methods for routine use.

         13. Breastfeeding. Breastfeeding is contraindicated with the use of MMF.

         14. Participation in another clinical research study involving the evaluation of another
             investigational drug within ninety days of entry into this study.

         15. The presence of severe lung disease as defined by a diffusion capacity of less than
             30% of predicted or requiring supplemental oxygen.

         16. History of HIV infection

         17. Known active bacterial, viral, fungal, mycobacterial, or other infection r any major
             episode of infection requiring hospitalization or treatment with IV antibiotics within
             4 weeks of screening, or oral antibiotics within 2 weeks prior to screening

         18. Any other disease, metabolic dysfunction, physical examination finding, or clinical
             laboratory finding giving reasonable suspicion of a disease or condition that
             contraindicates the use of an investigational drug or that may affect the
             interpretation of the results or render the patient at high risk from treatment
             complications

         19. Prior use of Belimumab, Rituximab, or other B-Cell depleting therapies ever

         20. The use of other biologics including TNF inhibitors, abatacept, or tocilizumab within
             1 month of enrollment [this is a safety issue]

         21. Patients with a history of severe depression, psychosis, or suicidal ideation will be
             excluded.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Robert Spiera, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01670565

Organization ID

12006


Responsible Party

Sponsor

Study Sponsor

Hospital for Special Surgery, New York

Collaborators

 Human Genome Sciences Inc.

Study Sponsor

Robert Spiera, MD, Principal Investigator, Hospital for Special Surgery, New York


Verification Date

March 2017