A phase II study to evaluate how safe and effective the study drug abatacept (injected subcutaneously) is compared to placebo in treating diffuse cutaneous systemic sclerosis
- Conditions
- Diffuse Cutaneous Systemic SclerosisMedDRA version: 18.0 Level: LLT Classification code 10010759 Term: Connective tissue disorder NOS System Organ Class: 100000004859MedDRA version: 18.0 Level: LLT Classification code 10018124 Term: Generalized scleroderma System Organ Class: 100000004859Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2014-005323-27-GB
- Lead Sponsor
- niversity of Michigan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 86
1. Signed Written Informed Consent
2. Diagnosis of SSc, as defined using the 2013 American College of Rheumatology/ European Union League Against Rheumatism classification of SSc
3. dcSSc as defined by LeRoy and Medsger
4. Disease duration of = 36 months (defined as time from the first non-Raynaud phenomenon manifestation)
For disease duration of = 18 months
? = 10 and = 25 mRSS units at the screening visit
For disease duration of >18-36 months
? = 15 and = 45 mRSS units at the screening visit and one of the following:
1. Increase = 3 in mRSS units compared with the last visit within previous 1–6 months
2. Involvement of one new body area with = 2 mRSS units compared with the last visit within the previous 1–6 months
3. Involvement of two new body areas with = 1 mRSS units compared with the last visit within the previous 1–6 months
4. Presence of 1 or more Tendon Friction Rub
5. Age = 18 years at the screening visit
6. If female of childbearing potential (see 4.2.3), the patient must have a negative pregnancy test at screening and baseline visits
7. Oral corticosteroids (= 10 mg/day of prednisone or equivalent) and NSAIDs are permitted if the patient is on a stable dose regimen for = 2 weeks prior to and including the baseline visit
8. ACE inhibitors, calcium-channel blockers, proton-pump inhibitors, and/or oral vasodilators are permitted if the patient is on a stable dose for = 2 weeks prior to and including the baseline visit
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range 0
1. Rheumatic disease other than dcSSc; it is acceptable to include patients with fibromyalgia and scleroderma-associated myopathy
2. Limited cutaneous SSc or sine scleroderma at the screening visit
3. Major surgery (including joint surgery) within 8 weeks prior to screening visit
4. Any infected ulcer prior to randomization
5. Treatment with any investigational agent within = 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of the baseline visit
6. Severe (MRSS 3+) skin on the inner aspects of thighs, upper arms, and abdomen
7. Previous treatment with cell-depleting therapies, including investigational agents, including but not limited to, CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19, and ABA
8. Anti-CD20, and cyclophosphamide within 12 months prior to the baseline visit
9. Use of Intravenous Immunoglobulin (IVIG) within12 weeks prior to the baseline visit
10. Previous treatment with chlorambucil, bone marrow transplantation, or total lymphoid irradiation
11. Immunization with a live/attenuated vaccine within = 4 weeks prior to the baseline visit
12. Treatment with methotrexate, hydroxychloroquine, cyclosporine A, azathioprine, mycophenolate mofetil rapamycin, colchicine, D-penicillamine, within = 4 weeks prior to the baseline visit
13. Treatment with etanercept within = 2 weeks, infliximab, certolizumab, golimumab, ABA or adalimumab within = 8 weeks, anakinra within = 1 week prior to the baseline visit
14. Pulmonary disease with FVC = 50% of predicted, or DLCO (uncorrected for hemoglobin) = 40% of predicted at the screening visit
15. Pulmonary arterial hypertension (PAH) as determined by right heart catheterization or on PAH approved medications for PAH. It is acceptable to use PDFE-5 inhibitors for Raynaud’s and digital ulcers.
16. Subjects at risk for tuberculosis (TB). Specifically excluded from this study will be participants with a history of active TB within the last 3 years, even if it was treated; a history of active TB greater than 3 years ago, unless there is documentation that the prior anti-TB treatment was appropriate in duration and type; current clinical, radiographic, or laboratory evidence of active TB; and latent TB that was not successfully treated (= 4 weeks).
17. Positive for hepatitis B surface antigen prior to the baseline visit
18. Positive for hepatitis C antigen, if the presence of hepatitis C virus was also shown with polymerase chain reaction or recombinant immunoblot assay prior to baseline visit
19. Any of the following prior to the baseline visit:
? Hemoglobin <8.5 g/dL;
? WBC < 3,000/mm3 (<3 x 109/L);
? platelets < 100,000/mm3 (<3 x 109/L);
? serum creatinine > 2 x ULN; or
? serum ALT or AST > 2 x ULN
20. Any other laboratory test results that, in the opinion of the investigator, might place a participant at unacceptable risk for participation in the study.
21. The following medical history and concurrent diseases:
Subjects who are impaired, incapacitated, or incapable of completing study-related assessments.
? Subjects with active va
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method