Addition of Modulators of Homocysteine to Adalimumab Therapy in the Treatment of Moderate to Severe Plaque Psoriasis

Wayne State University

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Psoriasis

Treatments: Drug: Humira Then Humira plus 3 B vitamins

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01704599

Dermatology 1104009591

Details and patient eligibility

About

Vitamins modulating homocysteine affect both TNF-alpha, vascular endothelial growth factor, and theoretically enhance the anti-inflammatory version of NOS thus hopefully increasing the efficacy and reducing the chance of some toxicities of adalimumab as determined by blood testing and EKGs.

Full description

This is a pilot study designed to evaluate whether addition of oral vitamin B12, vitamin B6, and folic acid to the use of adalimumab for psoriasis leads to further improvement of a patient's psoriasis and quality of life.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adults 18 or older
• moderate to severe plaque psoriasis (>10% BSA)
• Negative pregnancy test within 7 days before first dose of adalimumab in all women (except surgically sterile or 5 years postmenopausal)
• subject must sign/date appropriate written informed consent&HIPAA authorization
• Sexually active subjects of childbearing potential must agree to use medically acceptable contraception during screening and throughout the study
• no evidence of active or latent tuberculosis based on a negative PPD skin test performed at screening, or within one year of starting this study. Patients with documentation of adequately treated TB may be enrolled
• Patients PPD positive and CXR negative can be enrolled if they finish appropriate INH prophylaxis prior to enrollment
• be willing and able to self-administer subcutaneous injections or to have a qualified person available to administer these injections
• agrees to comply with protocol requirements, attend all regularly study visits and is considered to be a good study subject
• meets concomitant medication washout requirements
• willing to use only allowed psoriasis medications and treatments and agree not to start any topical, systemic, or phototherapy for psoriasis during the study period
• adalimumab naïve

Exclusion criteria

• erythrodermic, pustular, or guttate psoriasis
• skin conditions other than psoriasis that would interfere with study-related psoriasis evaluations
• known sensitivity to any component of the study medications
• Evidence of active infections such as fevers, chills, sweats, or history of untreated Lyme disease and active severe infections within 4 weeks before screening visit, or between the screening and Week 0 visits
• history of listeriosis, untreated TB, persistent or active infections requiring hospitalization or treatment with IV antibiotics, IV antiretrovirals, or IV antifungals within 30 days of baseline, OR oral antibiotics, antivirals, or antifungals for purpose of treating infection, within 14 days of baseline
• positive PPD and positive chest x-ray for latent or active tuberculosis
• positive PPD and negative chest x-ray that have not completed appropriate INH prophylaxis
• On immune compromising drug or history of immune compromising disorder or immunodeficiency
• poorly controlled medical condition including, not limited to, unstable cardiovascular disease, poorly controlled diabetes, recent stroke, history of recurrent infections, or any condition for which, in the opinion of the investigators, participation in the study would place the subject at risk
• hx. congestive heart failure
• hx. demyelinating CNS disease
• History of malignancy (other than previously treated localized carcinoma in situ of the cervix or previously treated nonmelanoma skin cancer)
• history of or ongoing drug or alcohol abuse
• past or present psychiatric morbidity which may compromise the study
• Pregnant women, nursing mothers, or planning to become pregnant during study or within 150 days after last dose of study medication. Males planning pregnancy with spouse/partner while in study are to be excluded
• plans to receive any live vaccines during study
• history of liver disease
• Current enrollment in another clinical study/treatment with other experimental drug or approved therapy for experimental use within 30 days prior to Week 0
• previous enrollment in this study
• cannot commit to all assessments required by the protocol
• disorder that compromises the subject to give written informed consent and/or comply with study procedures
• considered by the investigators to be unsuitable candidate
• cannot comply with the protocol washout requirements
• on folic acid in doses over than the minimal daily requirements
• on vitamins higher than minimal daily requirements (multivitamins are allowed)
• colon polyps or cancer
• prior adalimumab therapy
• on screening plasma Vascular Endothelial Growth Factor level is 140 pg/ml or more

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

8 participants in 1 patient group

Humira then Humira plus 3 B vitamins

Experimental group

Description:

Humira then Humira plus 3 B vitamins The only arm: After 16 weeks on adalimumab, modulators of homocysteine (oral vitamin B12, oral vitamin B6 or pyridoxine, and oral folic acid) will be added to adalimumab therapy for an additional 12 weeks. At end of this therapy can stop or continue. Telephone call day 70 after formal end of in person study the investigators will assess general health of each subject.

Treatment:

Drug: Humira Then Humira plus 3 B vitamins