Recruiting

H.P. Acthar Gel

Sponsor:

Iraj Sabahi Research Inc.

Code:

NCT03082573

Conditions

Rheumatoid Arthritis

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

H.P. Acthar gel

Study Details

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.

Conditions

Rheumatoid Arthritis

Study ID

NCT03082573

Start date

Mar 3, 2017

Status verified date

Mar, 2017

Completion date

Feb, 2019

Anticipated

Primary completion date

Feb, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Group A

Will be receiving the same background medications and H.P. Acthar gel 40 units twice weekly for 12 weeks.

Patients in group A, can be cross over to group B on week 13 if disease is uncontrolled for continuation until week 24. If their disease is under control then they will continue with the same dosage until week 24.

If the disease is under control, then tapering the steroid dosage can be attempted at the principal investigation's discretion.

active comparator: Group B

Will be receiving the same background medications and H.P. Acthar gel 80 units twice weekly for 12 weeks.

if the disease is not under control, will continue with same dosage until week 24. If the disease is under control, will be given the option to reduce the dosage to 40 units twice weekly only if patient is suffering from H.P. Acthar gel related adverse effects.

If the disease is under control, then tapering the steroid dosage can be attempted at the principal investigation's discretion.

Interventions

H.P. Acthar gel

H.P. Acthar gel in treatment of Refractory RA

Primary outcome measure

  • ACR 20 response ACR 20 response [ Time Frame: Baseline to week 12 ]

Central Contacts and Locations

Locations

Iraj Sabahi Research Inc

Recruiting

Pleasanton, California, United States, 94588

Contacts

Iraj Sabahi Research Inc

Recruiting

Turlock, California, United States, 95382

Contacts

More Information

Sponsor

Iraj Sabahi Research Inc.

Last update posted

Mar 17, 2017

Last verified

Mar, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Iraj Sabahi Research Inc. on 2017-03-17.