The Effect of Corticotrophin (ACTH) in Combination With Methotrexate in Newly Diagnosed Rheumatoid Arthritis Patients

NCT01948388 | Completed Phase 4 Results DMC

• 1 other identifier: RA2013-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Clinical Disease Activity Index (CDAI) Score

  To evaluate the effect of the use of 2 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 measured by Clinical Disease Activity Index (CDAI) scores. The CDAI is calculated at the specified time points using the formula: CDAI = SJC(28) + TJC(28) + PGA + EGA SJC(28): Swollen 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs including thumb IP, knees) Interpretation: A lower CDAI score from Baseline would mean improvement in disease activity and an increase in CDAI score from Baseline would mean an increase in disease activity or a worsening in disease activity. Scores: 0.0-2.8 = Range for Remission; 2.9-10.0 = Range for Low disease activity; 10.1-22.0 Range for Moderate disease activity; 22.1-76 Range for High disease activity.Total range is from 0-100, with the high scores representing high disease activity.

  Baseline, Month 3 and Month 6

Secondary Outcomes (3)

• Evaluation of MRI Structural Improvements

  Baseline, 3 months, 6 months

• Number of Participants With Increased or Decreased Erosions of the Hand and Wrist

  Month 3 and Month 6

• Comparison of Clinical Disease Activity Index (CDAI) Scores to Positive Magnetic Resonance Imaging (MRI) Findings

  Month 6

Other Outcomes (1)

• Participants With Increased and Decreased C-Reactive Protein (CRP) Values and Erythrocyte Sedimentation Rates (ESR)

  Month 6

Study Arms (2)

corticotrophin 80 units

ACTIVE COMPARATOR

Ten (10) patients will receive 80 units of corticotrophin Subcutaneous (SC) weekly

Drug: corticotrophin 80 units

corticotrophin 80 units twice a week

ACTIVE COMPARATOR

Ten (10) patients will receive 80 units of corticotrophin Subcutaneous (SC) twice a week

Drug: corticotrophin 80 units

Interventions

corticotrophin 80 units DRUG

Comparison of different dosages of the drug. Ten patients will receive 80 units of corticotrophin weekly. Ten patients will receive 80 units bi-weekly of corticotrophin

Also known as: Acthar, Corticotrophin, ACTH

corticotrophin 80 units; corticotrophin 80 units twice a week

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be at least 18 years old at the screening visit.
• Patient must be able to understand the information provided to them and to give written Informed Consent.
• 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 (ACTH).
• 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 year.
• 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
• A Baseline Magnetic Resonance Imaging ( MRI) must show the presence of osteitis or erosions in the hand or wrist.
• Patients must be able and willing to comply with the requirements of the study protocol.
• Patients must have a C-reactive Protein (CRP) or erythrocyte sedimentation rate (ESR) \> upper limits of normal

You may not qualify if:

• Patients who have a diagnosis of any other inflammatory arthritis (e.g., psoriatic arthritis or ankylosing spondylitis).
• Patients with exposure to any disease modifying antirheumatic drug (DMARD), Biologic, Non-biologic or experimental medication for the treatment of rheumatoid arthritis (RA).
• 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).
• Patients with history of an infected joint prosthesis at any time with that prosthesis still in situ.
• 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)
• 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.
• 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.
• 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.
• 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).
• 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).
• \. Patients with a current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease.
• \. Patients with class III or IV congestive heart failure according to the New York Heart Association (NYHA) 1964 classification criteria.

Sponsors & Collaborators

• Gaylis, Norman B., M.D.: lead

Study Sites (1)

AARDS Research, Inc

Aventura, Florida, 33180, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Adrenocorticotropic Hormone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Joanne Sagliani
• Organization: Arthritis & Rheumatic Disease Specialties

drnbg@rheum-care.com

3059324162

Study Officials

• Norman B Gaylis, MD

  AARDS Research, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2013
• First Posted: September 23, 2013
• Study Start: September 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 18, 2019
• Results First Posted: January 18, 2019

Record last verified: 2019-01

Locations

US (1)