Intervention: Cyanocobalamin
Trial phase: Phase 1 | Phase 2
ATC code: B03AE01 | B03BA01 | B03BA51
SMILES: C/C1=C2/N=C(/C=C3\N=C(/C(C)=C4/[C@@H](CCC(N)=O)[C@](C)(CC(N)=O)[C@](C)([C@@H]5N=C1[C@](C)(CCC(=O)NC[C@@H](C)OP(=O)([O-])O[C@H]1[C@@H](O)[C@@H](n6cnc7cc(C)c(C)cc76)O[C@@H]1CO)[C@H]5CC(N)=O)N4[Co+]C#N)[C@@](C)(CC(N)=O)[C@@H]3CCC(N)=O)C(C)(C)[C@@H]2CCC(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Pneumonia while on adaimumab and before the adalimumab plus B vitamins were begun.prior to vitamins
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