| Scleroderma Clinical Trials (MAIN MENU) |
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| Completed Scleroderma Clinical Trials: Positive Results |
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| Bosentan, Tracleer |
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| Combination Therapies |
| Therapeutic strategy combining intravenous cyclophosphamide followed by oral azathioprine to treat worsening interstitial lung disease associated with systemic sclerosis: a retrospective multicenter open-label study. Intravenous CYC followed by oral maintenance immunosuppressive therapy for worsening ILD was well tolerated and was associated with stable or improved PFT in 70% and 51.8% of SSc patients at 6 months and 2 years, respectively. Bérezné A. J Rheumatol. 2008 Jun;35(6):1064-72. |
| Electrophoresis with Ximedon |
| Closed Study, Positive Results |
| Discovery May Lead to Novel Treatments for Autoimmune and Chronic Inflammatory Diseases. For years, doctors have used IVIG to treat patients with autoimmune and chronic inflammatory diseases, but just how the therapy works has remained a mystery. Some researchers have shown that IVIG works, in part, by activating a receptor known as FcγRIIb, which then suppresses auto-antibody-mediated inflammation. Newswise. 01/26/07. (Also see: Medications, Dermatomyositis, and Myasthenia Gravis) |
| A double blind placebo-controlled trial performed in 56 patients with scleroderma systematica showed effectiveness of a domestic drug ximedon--a pirimidine compound--applied during electrophoresis on the affected skin, limbs. The addition of ximedon-electrophoresis to rehabilitation program for scleroderma systematica improved the condition in 77.8%, microhemo-circulation in 72.2%, reduced the area of the affected skin by 9.8% (p < 0.05), skin induration in 55.6% of patients. PubMed. Vopr Kurortol Fizioter Lech Fiz Kult 2002 Sep-Oct;(5):33-6. |
| Halofuginone |
| Closed Study, Positive Results |
| Halofuginone to treat fibrosis in chronic graft-versus-host disease and scleroderma. The results of the human studies provide basis for using halofuginone treatment for dermal fibrosis. As a first step toward future treatment of internal organ involvement, an oral administration study was performed in which halofuginone was well tolerated and plasma levels surpassed the predicted therapeutic exposure. PubMed. Biol Blood Marrow Transplant. 2003 Jul;9(7):417-25. (Also see: Skin Fibrosis and Diseases Similar to Scleroderma) |
| Infliximab |
| Open-label pilor study completed. Positive results. |
| An open-label pilot study of infliximab therapy in diffuse cutaneous systemic sclerosis. In diffuse cutaneous systemic sclerosis (dcSSc), infliximab did not show clear benefit at 26 weeks but was associated with clinical stabilisation and a fall in two laboratory markers of collagen synthesis. The frequency of suspected infusion reactions may warrant additional immunosuppression in any future studies in systemic sclerosis. Annals of the rheumatic diseases, 2009, vol. 68, no9. |
| Intravenous Immunoglobulins (IVIg) |
| Closed Studies, Positive Results |
| Limited effects of high-dose intravenous immunoglobulin (IVIG) treatment on molecular expression in muscle tissue of patients with inflammatory myopathies. The clinical effects of high-dose IVIG on muscle function in patients with refractory inflammatory active myositis did not correspond to effects on any of the investigated molecules in our study. Annals of the Rheumatic Diseases 2007;66:1276-1283. (Also see: Polymyositis and Dermatomyositis) |
| Intravenous immunoglobulins (IVIG) improve the function and ameliorate joint involvement in systemic sclerosis: a pilot study. This pilot study suggests that IVIg may reduce joint pain and tenderness with a significant recovery of joint function in SSc patients with severe and refractory joint involvement. IVIg cost might limit their use only to patients that failed DMARDs. PubMed. Ann Rheum Dis. 2007 Mar 7. |
| Mainstream Medications for Scleroderma (IVIg). ISN. |
| Methotrexate |
| Tumor necrosis factor blockers may not cause cancer after all. Study finds no increased risk of lymphoma or tumors associated with anti-TNF therapy over methotrexate use among rheumatoid arthritis patients. EurekAlert! 08/31/06. (Also see: Rheumatoid Arthritis) |
| Interstitial Pneumonitis Associated with Infliximab Therapy. Interstitial pneumonitis is a well documented, rare complication of methotrexate (MTX). Infliximab may potentiate pulmonary toxicity of MTX. J Rheumatol 2006;33:1189–93. |
| Small study completed. Positive results, but not statistically significant. |
| Evaluation of oral methotrexate in the treatment of systemic sclerosis. It was concluded that methotrexate for 6 months only provides subjective improvement, and further studies after 1 year of treatment with methotrexate are recommended. PubMed. Int J Dermatol. 2007 Feb;46(2):218-23. (Also see: Medications) |
| Placebo controlled trial of methotrexate in systemic sclerosis. Clinical improvement following treatment was observed in 33.33% of the patient in MTX group but none in placebo group, but this difference was not statistically significant. Anorexia, nausea and occasional vomiting were common side effects in MTX group and subsided in most cases with the passage of time despite the continuation of therapy. PubMed. Mymensingh Med J. 2005 Jan;14(1):71-4. (Also see: Medications) |
| Methotrexate pneumonitis: review of the literature and histopathological findings in nine patients. Pneumonitis is a serious and unpredictable side-effect of treatment with methotrexate (MTX) that may become life-threatening. The clinical and histological features of nine cases of MTX pneumonitis are reported and the literature reviewed. Eur Respir J. 2000 Feb;15(2):373-81. |
| Methotrexate (Rheumatrex ®) Open enrollment in clinical trial SCTC |
| About Methotrexate (Rheumatrex, Trexall) MedicineNet |
| Pheresis |
| No current studies. |
| A randomized, double-blind, placebo-controlled trial of photopheresis in systemic sclerosis. Photopheresis induced significant improvement of skin and joint involvement in patients with scleroderma of recent onset; however, any effect when compared with sham treatment and a possible placebo effect may be modest. PubMed. J Am Acad Dermatol. 2006 May;54(5):793-799. |
| Extracorporeal photochemopheresis in scleroderma YalePhotobiology Lab |
| Photopheresis: new immunomodulatory therapy for T-lymphocyte mediated diseases. PubMed. An Med Interna. 2003 Aug;20(8):421-426. |
| Pirfenidone |
| Positive Results. |
| Positive Data From Lung Study May Lead to First FDA Approved Treatment for Pulmonary Fibrosis PF). A pivotal Phase III clinical trial is completed for Pirfenidone and data released. The positive data could pave the way for the first FDA-approved therapy to treat PF. Breakthrough Digest. 02/04/09. (Also see: Pulmonary Fibrosis) |
| PUVA/UVA-1 and Phototherapy |
| Positive Results. |
| Photodynamic therapy: other uses. The ability of this treatment to hone in on dysplastic epithelial and endothelial cells while retaining viability of surrounding tissue is its key feature because this leads to specific tumor destruction with cosmesis and function of the target organ intact. PubMed. Dermatol Clin. 2007 Jan;25(1):101-9. (Also see: Skin Fibrosis and Morphea Treatments) |
| Phototherapy: a promising treatment option for skin sclerosis in scleroderma? Phototherapy is able to stop or inhibit the fibrotic processes and to induce softening of sclerotic skin, especially in limited SSc. Rheumatology (Oxford). 2006 Oct;45 Suppl 3:iii52-iii54. (Also see: Skin Fibrosis) |
| A randomized controlled study of low-dose UVA1, medium-dose UVA1, and narrowband UVB phototherapy in the treatment of localized scleroderma (LS). Phototherapy, as previously reported in several noncontrolled trials, is an effective therapeutic option in LS, with a favorable risk/benefit ratio. UVA1 phototherapy should be considered among the first approaches in the management of LS. PubMed. J Am Acad Dermatol. 2006 Mar;54(3):440-7. (Also see: Localized Scleroderma) |
| Quantitative echographic analysis of photochemotherapy on systemic sclerosis skin. Photochemotherapy was more likely to improve dermal edema, not fibrosis, because echo intensity after treatment was significantly elevated with that before treatment in patients with edema. Quantitative echographic analysis was concluded to be a reliable method in evaluating the change of skin edema in SSc. PubMed. Arch Dermatol Res. 2005 Apr 1. (Also see: Skin Involvement) |
| UVA/UVA1 phototherapy and PUVA photochemotherapy in connective tissue diseases and related disorders: a research based review. Even though holding the risk of carcinogenesis, photoaging or UV-induced exacerbation, UVA phototherapy seems to exhibit a tolerable risk/benefit ratio at least in systemic sclerosis, localized scleroderma, extragenital lichen sclerosus et atrophicus, sclerodermoid graft-versus-host disease, lupus erythematosus and a number of sclerotic rarities. PubMed. BMC Dermatol. 2004 Sep 20;4(1):11./i> |
| Ultraviolet A1 phototherapy. Another condition for which UVA1 is effective, and is particularly promising because we have no reliably effective treatment already, is localized scleroderma. PubMed. Br J Dermatol 2003 Apr;148(4):626-37 (Also see: Linear and Morphea) |
| Altered decorin expression of systemic sclerosis by UVA1 (340?400 nm) phototherapy: Immunohistochemical analysis of 3 cases. (Full Text) Ultraviolet A1 (UVA1) phototherapy is highly effective in sclerotic lesions of systemic sclerosis. These results suggest that decreased and normalized levels of accumulated decorin may relate to the efficacy of sclerotic lesions in UVA1 phototherapy. MC Dermatol 2003 Mar 12;3(1):2. |
| Influence of 5-aminolevulinic Acid and red light on collagen metabolism of human dermal fibroblasts. Patients with localized scleroderma receiving topical photodynamic therapy with 5-aminolevulinic acid show a reduction in skin tightness, suggesting that this therapy reduces skin sclerosis. PubMed. J Invest Dermatol 2003 Feb;120(2):325-31. |
| PVAC |
| Positive Results. |
| PVAC: A Randomized, Blinded, Parallel Group, Placebo-Controlled, Pilot Study Evaluating The Effect Of PVAC Treatment In Patients With Diffuse Systemic Sclerosis. Use of PVAC in this pilot study of PSS appeared safe and was associated with a trend toward improved skin scores and other efficacy outcomes in the 15 ìg treatment group. However, no dose response relationship was seen. Additional evaluation of this therapeutic approach is warranted. Mark C. Genovese. 1695/520. ACR 2004. |
| Rituximab (Rituxan) |
| Rituximab in diffuse cutaneous systemic sclerosis (dc-SSc): an open-label clinical and histopathological study. Rituximab appears to be well-tolerated and may have potential efficacy for skin disease in dc-SSc. V P Smith. Annals of Rheumatic Diseases. 22 December 2008. (Also See: Mainstream Medications) |
| Thalidomide |
| Enrollment closed. Positive initial results from 2000, larger study needed. |
| T cell immunity in collagen biosynthesis of scleroderma This project studies the immune modulatory effects of the drug thalidomide on the fibrosis of scleroderma. New York University School of Medicine. |
| Urokinase Therapy |
| Postive results for skin involvement in systemic scleroderma. |
| Urokinase Improves Sclerodermic Skin Pathology in Patients with Systemic Sclerosis. Gradual clinical improvement was observed with urokinase therapy, as evidenced by a noticeable restoration of skin elasticity and softness. Moreover, patients reported less intense symptoms of Raynaud's phenomenon and improvements in articular range, including previously limited movements. The authors conclude that "therapy with urokinase seems to be a rational treatment in this disease" as it appears to "modify the course and evolution of systemic sclerosis." Doctor's Guide. 01/21/04. Scand J Rheumatol 2003;32:5:261-7. |
| Clinical improvement in systemic sclerosis resulting from urokinase therapy explained by light and electron microscopy skin examination. These observations show that urokinase treatment seems to be an interesting therapeutic strategy to consider for the treatment of SSc. PubMed. Scand J Rheumatol. 2003;32(5):261-7. |
| See Also |
Sjögren's Treatments & Clinical Trials
Scleroderma Medical News
Scleroderma Symptoms (treatments are listed for each symptom) |
