Rheumatoid Arthritis
Conditions
Brief summary
This study will examine the clinical response, cytokine expression and joint imaging after addition of Acthar Gel. The hypothesis is that H.P. Acthar Gel is both safe and effective for treatment of patients with refractory rheumatoid arthritis (RA) and has different mechanism of action than steroids and other DMARDs.
Detailed description
Rheumatoid arthritis (RA) is a systemic inflammatory disease which causes premature mortality, disability and compromised quality of life in the industrialized and developing world. The prevalence of RA is believed to range from 0.5-1.0% in the general population. Over the past half century, many studies have found mortality to be increased in patients with established RA in comparison with the general population. Despite available treatment options for RA, some patients still have disease that is refractory to treatment and cannot achieve remission. H.P. Acthar gel (adrenocorticotropic hormone gel) received FDA approval for treatment of a variety of diseases, including RA in 1952. The proposed efficacy of H.P. Acthar gel has been attributed to its ability to induce production of endogenous steroids and to bind melanocortin receptors on lymphocytes and other cells to modulate immunologic responses. The present study will examine the clinical response, cytokine production and joint imaging after addition of H.P. Acthar gel to confirm the efficacy, confirm different mechanism of action in comparison to steroids and other DMARDs by looking for post treatment changes in cytokine expression.
Interventions
DRUGH.P. Acthar gel
H.P. Acthar gel in treatment of Refractory RA
Sponsors
Mallinckrodt
Iraj Sabahi Research Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open Label
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with diagnosis of RA with incomplete or failure to treatment described as either A or B A: Failure to achieve remission or low disease activity within 3 to 6 months of treatment with combination of methotrexate or other DMARDs therapy with a biologic DMARD in maximally tolerated doses within the usual therapeutic range. B- A requirement, in addition to DMARDs and biologic DMARDs, for chronic glucocorticoid therapy in a dose of greater than about 5 to 7.5 mg/day of prednisone or equivalent to achieve or maintain remission or low disease activity after 3 to 6 months of treatment. 2. Fluent in reading and writing in English language. 3. ≥ 21 years of age at the time of participation.
Exclusion criteria
1. Pregnancy 2. Presence if contraindications for treatment with H.P. Acthar gel including but not limited to any known history of scleroderma, osteoporosis, systemic fungal infections, ocular Herpes Simplex, recent administration of live or live attenuated vaccine (prior 6 months), recent surgery (prior 6 months), history of or the presence of a peptic ulcer, primary adrenocortical insufficiency, adrenal cortical hyperfunction; congestive heart failure (defined as New York Hear Association Functional Class I to IV, uncontrolled hypertension. 3. Previous use of ACTH preparations for treatment of nephrotic syndrome (including but not limited to H.P. Acthar gel and Synacthen®). 4. Previous history of sensitivity to ACTH preparations (including but not limited to H.P. Acthar gel and Synacthen®). 5. Previous history of sensitivity to porcine protein products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ACR 20 response ACR 20 response | Baseline to week 12 | Equal or greater than 20 % reduction in RA disease activity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of Powered Doppler Signal of MSKUS studies | Baseline to week 24 | Decline or resolution of synovitis detected in ultra sonographic examination of joints |
| ACR 50 response | Baseline to week 24 | Equal or greater than 50 % reduction in RA disease activity |
| ACR 70 response | Baseline to week 24 | Equal or greater than 70 % reduction in RA disease activity |
| EULAR moderate response | Baseline to week 24 | Decline in the DAS 28 score by \>1.2 (without reaching low disease activity) OR The decline of 0.6 to 1.2, plus reaching at least moderate disease activity (DAS28 \<5.1). |
| EULAR good response | Baseline to week 24 | Decline in DAS 28 score must exceed 1.2 and result in the achievement of low disease activity (DAS28 \<3.2). |
| Reduction in Vectra DA Score | Baseline to week 24 | Decline in RA disease activity manifested as decline in Vectra DA Score |
| Correlation between MSKUS and MRI Imaging findings | Baseline to week 24 | Comparison between MSKUS and MRI imaging |
| Correlation between imaging findings and Vectra DA test | Baseline to week 24 | Comparison between MSKUS/MRI findings and Vectra DA test results |
| Resolution of signs of active inflammation in MRI | Baseline to week 24 | Decline or resolution of synovitis, tenosynovitis or bone edema detected in MRI examination of joints |
Countries
United States
Contacts
Primary ContactIraj Sabahi, MD
Backup ContactSonia Dimas
Outcome results
None listed