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

What Was Tested

This registered phase 1, phase 2 trial tested Cyanocobalamin (Vitamin B12) for psoriasis and psoriatic arthritis.

It had 1 arm (groups): Humira then Humira plus 3 B vitamins (experimental).

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.

The registry classes the interventions as drug.

Who Took Part

The registry lists 8 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adults 18 or older. 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. 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.

The full record lists 12 inclusion and 28 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: single-group and open-label.

Nothing was hidden in this open-label Cyanocobalamin (Vitamin B12) study: the psoriasis and psoriatic arthritis participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2009-01 with completion listed for 2013-06.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Particpants With a Categorical PASI (Psoriasis Area and Severity Index) Change (time frame: Weeks 16 and 28).

It also tracked 7 secondary outcomes, for example Number of Participants With a Categorical Change in Static Physician Global Assessment (sPGA):, Number of Participants With a Categorical DLQI (Dermatology Life Quality Index) Change, Number of Participants With Category Change in Serum VEGF (Vascular Endothelial Growth Factorl), Number of Participants With Category Change in Vitamin B12 Blood Level and Number of Participants With Category Change in Serum Folic Acid Level.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2 trial of Cyanocobalamin (Vitamin B12) in 8 people with psoriasis and psoriatic arthritis.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Cyanocobalamin (Vitamin B12) compound page, Psoriasis and psoriatic arthritis research.