Clinical trial NCT01704599 (phase 1/phase 2, status: terminated)
Conditions: psoriasis
ICD codes: L40.0, L40.4, L40.8, L40.9, L40.1, L40.50
Drugs: humira then humira plus 3 b vitamins
SMILES: NC1=NC(=O)C2=NC(CNC3=CC=C(C=C3)C(=O)N[C@@H](CCC(O)=O)C(O)=O)=CN=C2N1
Reason stopped: 
    side effect and poor clinical outcome
  
Eligibility criteria:

        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