The purpose of the study is to evaluate the effect of the utilization of two doses of
corticotrophin ( ACTH) as a treatment in patients with early onset rheumatoid arthritis as
an alternative to conventional steroid therapy by evaluating the change from baseline in the
clinical findings as well as the structural findings on Magnetic Resonance Imaging (MRI).
Corticotrophin (ACTH) may prevent the well documented structural progression damage in RA
patients using disease-modifying antirheumatic drug (DMARD) therapy alone.
This is a Phase II 24-week open-label study to evaluate the efficacy and safety of H.P.
Acthar Gel Respository Injection, Corticotrophin( ACTH) administered to newly diagnosed
patients with rheumatoid arthritis in conjunction with methotrexate, folllowed by a 24 week
follow-up period. There will be a total of twenty (20) patients and two (2) treatment groups
with 10 patients in each treatment group
1. Patient must be at least 18 years old at the screening visit.
2. Patient must be able to understand the information provided to them and to give
written Informed Consent.
3. Female patients must be either postmenopausal for at least 1 year, surgically
incapable of childbearing, or effectively practicing an acceptable method of
contraception (oral/parenteral/implantable hormonal contraceptives, Intrauterine
Device (IUD), or barrier and spermicide). Abstinence only is not an acceptable
method. Patients must agree to use adequate contraception during the study and for 4
weeks after their last dose of corticotrophin (ACTH). Male patients must agree to
ensure they or their female partner(s) are using adequate contraception during the
study and for 4 weeks after the patient receives their last dose of corticotrophin
4. Patients must have a new diagnosis of adult-onset rheumatoid arthritis (RA) as
defined by the 2010 European League Against Rheumatism/American College of
Rheumatology (EULAR/ACR) classification criteria and who have had symptoms for <1
5. Patients must be experiencing mild to moderate rheumatoid arthritis ( RA), have at
least 6 tender and 6 swollen joints at screening and a clinical disease activity
index (CDAI) score of > 6.0
6. A Baseline Magnetic Resonance Imaging ( MRI) must show the presence of osteitis or
erosions in the hand or wrist.
7. Patients must be able and willing to comply with the requirements of the study
8. Patients must have a C-reactive Protein (CRP) or erythrocyte sedimentation rate (ESR)
> upper limits of normal
1. Patients who have a diagnosis of any other inflammatory arthritis (e.g., psoriatic
arthritis or ankylosing spondylitis).
2. Patients with exposure to any disease modifying antirheumatic drug (DMARD), Biologic,
Non-biologic or experimental medication for the treatment of rheumatoid arthritis
3. Patients with a non-inflammatory type of arthritis (e.g. osteoarthritis or
fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere
with evaluation of the effect of study drug on the patient's primary diagnosis of
rheumatoid arthritis (RA).
4. Patients with history of an infected joint prosthesis at any time with that
prosthesis still in situ.
5. Patients have received prohibited medication:
- non-steroidal anti-inflammatory drug (NSAIDs /COX-2 inhibitors) (any change in
dose regimen in the 7 days prior to baseline)
- Oral corticosteroids within 4 weeks of baseline
- Intra-muscular, intra-venous, intra-articular (IM/IV/IA) corticosteroids/
Intra-articular (IA) Hyaluronic acid (any dose 28 days prior to baseline)
6. Female patients who are breast-feeding, pregnant, or plan to become pregnant during
the trial or within twelve weeks following last dose of study drug.
7. Patients with a history of chronic infection due to fungal, parasitic or mycotic
pathogens during the preceding year, recent serious or life-threatening infection
within 6 months (including herpes zoster), or any current sign or symptom that may
indicate an infection.
8. Patients with active Tuberculosis (TB) (or history of active TB), positive chest
X-ray for TB, or positive (defined as induration of ≥ 5mm) purified protein
derivative (PPD) skin test, positive QuantiFERON, or patients having close contact
with an individual with active TB. Patients having a PPD skin test ≥ 5 mm or a
positive QuantiFERON test can enter the study, provided that active TB is excluded
and provided that they are adequately treated for latent TB (e.g., isonicotinic acid
hydrazide [INH therapy] for 9 months [with vitamin B6]) and provided that appropriate
treatment is initiated simultaneously with the first administration of ACTH.
9. Patients at a high risk of infection (e.g. leg ulcers, indwelling urinary catheter
and persistent or recurrent chest infections and patients who are permanently
bedridden or wheelchair bound).
10. Patients with a known allergy or intolerance to steroids 11 Concurrent malignancy or
a history of malignancy (other than carcinoma of the cervix or basal cell carcinoma
successfully treated more than 5 years prior to screening).
12. Patients with a current or recent history of severe, progressive, and/or uncontrolled
renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac,
neurological or cerebral disease.
13. Patients with class III or IV congestive heart failure according to the New York Heart
Association (NYHA) 1964 classification criteria.
14. Patients with a history of, or suspected, demyelinating disease of the central nervous
system (e.g. multiple sclerosis or optic neuritis).
15. Patients with any other condition (e.g. clinically significant laboratory values)
which in the Investigator's judgment would make the patient unsuitable for inclusion in
16. Patients who have a metal device affected by MRI (e.g., any type of electronic,
mechanical, or magnetic implant; cardiac pacemaker; aneurysm clip(s); implanted
cardioverter defibrillator; or a cochlear implant) 17. Patients who have a potential
ferromagnetic foreign body (metal slivers, metal shavings, other metal objects) for which
they have sought medical attention.
18. Concurrent steroid use for any concomitant disease. 19. Subjects who are known to be
Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C positive