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side effect and poor clinical outcome
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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Humira Then Humira plus 3 B vitamins | Drug | Humira alone for 16 weeks then Humira plus 100 mg daily pyridoxine, 5 mg daily folic acid and 1000 mcg daily cyanocobalamin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Particpants With a Categorical PASI (Psoriasis Area and Severity Index) Change | PASI: formula based on body surface areas on head/neck, trunk, both arms & legs with disease quality grading induration, scale and erythema on participants ages 18-65 with moderate to severe plaque psoriasis measured at weeks 16 and 28. | Weeks 16 and 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Categorical Change in Static Physician Global Assessment (sPGA): | Number of participants with a category change in Physician static Global Assessment (sPGA): 7 point score from 0 (clear) to 6 measuring amount of surface covered and plaque qualities: thickness & erythema plus scaling. Dynamic score compares baseline with either improvement/ worsening of the same factors measured in the sPGA using the 0-6 scoring range but focused on change. sPGA at weeks 16 AND 28. dynamic PGA to be categoically measured at.weeks16 and 28. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants in the Categories of Having and Not Having an Adverse Event | Worsening psoriasis or development or worsening of measured condition or new pathology not seen by week 16 but developed at weeks 28 or first discoved by telephone call day 70 post study: AE Humira only | After Week 16 of study |
| Number of Participants in the Categories of Having and of Not Having a Serious Adverse Event (SAE) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter J Aronson, MD | Department Dermatology Wayne State University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20514802 | Background | Aronson PJ, Malick F. Towards rational treatment of severe psoriasis in alcoholics: report of two cases. J Drugs Dermatol. 2010 Apr;9(4):405-8. | |
| 17087779 | Background | Moat SJ, Madhavan A, Taylor SY, Payne N, Allen RH, Stabler SP, Goodfellow J, McDowell IF, Lewis MJ, Lang D. High- but not low-dose folic acid improves endothelial function in coronary artery disease. Eur J Clin Invest. 2006 Dec;36(12):850-9. doi: 10.1111/j.1365-2362.2006.01739.x. |
| Label | URL |
|---|---|
| Search for Humira | View source |
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There were 11 potential subjects analyzed of which 3 were not enrolled prior to study assignment. The 3 did not meet study criteria.
All subjects were recruited at one of the Two Wayne State University Physician Group Dermatology clinics . Recruitment began Oct 2010 and lasted until 2012
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| ID | Title | Description |
|---|---|---|
| FG000 | Humira Then Humira Plus 3 B Vitamins | Humira then Humira plus 3 B vitamins The one 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. Humira Then Humira plus 3 B vitamins: Humira alone for 16 weeks then Humira plus 100 mg daily pyridoxine, 5 mg daily folic acid and 1000 mcg daily cyanocobalamin |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
5 male 3 female Adults over age 18 < or = 65 7 Adults over age 65 1
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| ID | Title | Description |
|---|---|---|
| BG000 | Humira Then Humira Plus 3 B Vitamins | 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. Humira Then Humira plus 3 B vitamins: Humira alone for 16 weeks then Humira plus 100 mg daily pyridoxine, 5 mg daily folic acid and 1000 mcg daily cyanocobalamin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Number of Participants With a Categorical Change in Static Physician Global Assessment (sPGA): | Number of participants with a category change in Physician static Global Assessment (sPGA): 7 point score from 0 (clear) to 6 measuring amount of surface covered and plaque qualities: thickness & erythema plus scaling. Dynamic score compares baseline with either improvement/ worsening of the same factors measured in the sPGA using the 0-6 scoring range but focused on change. sPGA at weeks 16 AND 28. dynamic PGA to be categoically measured at.weeks16 and 28. | 8 adult participants with moderate to severe plaque psoriasis. 7 had static PGA scores weeks 16 and 28 and one had sPGA but SAE prior to week 16. | Posted | Number | participants | Week 16 and Week 28 |
|
2010-2013
On Humira alone: WBC elevation, Non specific st-t wave change and Left axis deviation. .
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Humira Then Humira Plus 3 B Vitamins | Pneumonia while on adaimumab and before the adalimumab plus B vitamins were begun.prior to vitamins |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | SAE | Non-systematic Assessment | Pneumonia while on adalimumab before vitamins. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| left axis deviation | Cardiac disorders | Arrthymia | Non-systematic Assessment | EKG change one on Humira alone the otehr on drug plus vitamines (note: the fisrt subject with left axis deviation became normal after on vitamins were added) |
Early termination due to high amount of combination of side effects and poor outcomes leading to small numbers of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter J. Aronson, MD | Dept. Dermatology Wayne StateUniversity | (313)_745-7845 | paronson@med.wayne.edu |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| D025101 | Vitamin B 6 |
| D011736 | Pyridoxine |
| D005492 | Folic Acid |
| D014805 | Vitamin B 12 |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| Week 16 and Week 28 |
| Number of Participants With a Categorical DLQI (Dermatology Life Quality Index) Change | DLQI is 10 questions examining impact of skin disease on quality of life: (1) symptoms & feelings (2) daily activities (3) leisure (4) work & school (5) personal relationship (6) treatment. To be administered to adults over 18 years with moderate to severe plaque psoriasis at week 0 (no systemic psoriasis medication);. weeks 16 ( after 16 weeks of adalimumab) and week 28 (after 16 weeks adalimumab then 12 weeks of adalimumab plus daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12). | Week 16 and Week 28 |
| Number of Participants With Category Change in Serum VEGF (Vascular Endothelial Growth Factorl) | Adult particpants ages 18 or older with moderate to severe plaque psoriasis were to have serum VEGF measured at week 0 on no systemic psoriasis medication then at both weeks 16 on adalimumab and at week 28 on adalimumab plus folic acid, B6 and Vitamin B12. Subjects raniked by BMI week 0 low to high | At Screening visit, Week 16 on Humira, after another 12 weeks on Humira plus vitamins and if early termination |
| Number of Participants Within the Categories of Increasing and Decreasing Serum Homocysteine | Serum homocysteine measured at week 16 after 16 weeks of adalimumab and week 28 after 16 weeks of adalimumaband then 12 weeks of adalimumab plus 5 mg folic acid, 100mg B6 and 1000 mcg of B12 in adults ages 18-65 with moderate to sever plaque psoriasis.. | Week 16 and Week 28 |
| Number of Participants With Category Change in Vitamin B12 Blood Level | Adult participants 18 years or older with moderate to severe plaque psoriasis were to have serum B12 levels measures Weeks 0 (on no systemic psoriasis medication), 16 (on adalimumab) and week 28 (on adalimumab plus daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12. | At Week 16 and Week 28 |
| Number of Participants Within the Categories of Increasing and Decreasing Serum Vitamin B6 Level | Serum vitamin B6 levels were to be measured weeks16 after 16 weeks adalimumab and at week 28 after 16 weeks adalimumab and 12 weeks on adalimuamb, folic acid 5 mg, b6 100 mg and B12 1000 mcg in adult participants with moderate to sever plque psoriasis. | At Week 16 and Week 28 |
| Number of Participants With Category Change in Serum Folic Acid Level. | Serum folic acid level in adults ages 18 and older with mild to moderate plaque psoriasis measured at week 16 after 16 weeks adalimumab and at week 28 after 16 weeks adalimumab plus 12 weeks of adalimumab and daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12. | Weeks 16 and 28 |
A serious adverse event is hosptalization or death or pathology leading to early termination of a participant from the study. This was to be reported at anytime during the 28 week study of adult patients ages 18-65 with moderate to severe plaque psoriasis though categorized by Week 16 (on adalimumab alone, by Week 28 (on adalimuamb plus 3 B vitaminsand by day 70 post Week 28. |
| By Week 16, by Week 28 and by Day 70 post Week 28. |
| Number of Participants in the Categories of Normalizing, Unchanging and Newly Abnormal Electrocardiograms (EKGs) | An electrocardiogram (EKG) is used to evaluate the electrical activity of the heart by converting this activity into line tracings on paper.. Electrodes (small, plastic patches) are placed at certain locations on the chest, arms, and legs. When the electrodes are connected to an EKG machine by lead wires, the electrical activity of the heart is measured, interpreted, and printed out for the doctor's information and further interpretation. This test was to be administered to adults age 18 or older with moderate to severe plaque psoriasis patients at week 0, 16 and week 28 of this study. | Week 16 and then Week 28 after another 12 weeks on Humira plus vitamins and if early termination |
| Number of Participants in Categories or Increasing and Decreasing Changes Within the CBC (Complete Blood Count) | Change in CBC parameter: white blood count or hemoglobin or hematocrit ( as measured week 16 on adalimumab and at week 28 after 12 more weeks on adalimuamb , folic acid, B6 and B12) in adults ages 18-65 with moderate to severe plaque psoriasis. | Week 16 and Week 28 |
| Number of Participants Within the Categories of Increasing and Decreasing Serum Magnesium | Serum magnesium (Mg) was to be measured at baseline, Week 16 (on adalimumab) and at week 28 (on adalimumab plus folic acid, vitamins B6 and B12) in adult participants age 18 or older with moderate to severe plaque psoriasis. | Weeks 16 and 28 |
| Number of Participants Within the Categories of Increasing and Decreasing Serum Phosphorus | Serum phosphorus (P) levels were to be measured weeks16 and 28 in adult participants age 18 and older with moderate to severe plaque psoriasis at week 0 on no systemic psoriasis medication; week 16 after 16 weeks of adalimumab and at week 28 after 16 weeks of adalimumab plus 12 weeks of adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of B12. | Week 16 then Week 28 |
| Number of Participants Within the Categories of Elevated and Normal Helicobacter Pylori Antibody | Adult participants age 18 years or older with moderate to severe plaque psoriasis with serum IgG antibodies against Helicobacter pylori bacteria using commercial ELISA assay during the 28 week study. | Week 28 after 16 weeks of Adalimumab then 12 of Adalimumab-Vitamins |
| Number of Participants Within the Categories of Positive Urine Pregnancy Test (Urine Hcg) | Women of childbearing years over age 18 with moderate to severe plaque psoriasis on no systemic therapy at week 0 of study. | At screening |
| Number of Participants Within the Categories of Increasing and Decreasing Blood Pressure and Pulse Measures: | Blood pressure is the force the heart exerts against the walls of arteries as it pumps the blood out to the body. The unit of measurement is millimeters of mercury (mm Hg). Pulse is the number of times your heart beats per minute. The unit of measurement is beats per minute (BPM). These test measurements compared in adults with moderate to severe plaque psoriasis week 16 after 16 weeks adalimumab and week 28 after 16 weeks adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg vitamin B12. | Week 16 and Week 28 |
| Number of Participants Within Categories of Body Temperature Change | Using a thermometer for body temperature on degrees Fahrenheit. Participants to be measured were adults 18 years or older with moderate to severe plaque psoriasis with temperature to be measured at week 16 16 weeks of adalimumab and week 28 after 16 weeks of adalimumab then 12 weeks of adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of B12. | Weeks 16 and 28 |
| Number of Participants Who Fulfilled the Category of Having Height Measured | Height is the distance from the bottom (soles of feet ) to the top (top of head) of a person when that person is standing in this study using ruler in inches.Participants measured were adults age 18 or older with moderate to severe plaque psoriasis. | Week 0 at Start of Adalimumab |
| Number of Participants Within the Categories of Increasign and Decreasing Body Weight | Weight is how heavy a participant is. Weight in pounds of each study adult participant age 18-65 years with moderate to severe plaque psoriasis measured at weeks 16 and compared to week 28 of study. | Week 16 and Week 28 |
| 10553943 | Background | Li W, Zheng T, Wang J, Altura BT, Altura BM. Extracellular magnesium regulates effects of vitamin B6, B12 and folate on homocysteinemia-induced depletion of intracellular free magnesium ions in canine cerebral vascular smooth muscle cells: possible relationship to [Ca2+]i, atherogenesis and stroke. Neurosci Lett. 1999 Oct 22;274(2):83-6. doi: 10.1016/s0304-3940(99)00683-7. |
| 15083785 | Background | Lewis V, Finlay AY. 10 years experience of the Dermatology Life Quality Index (DLQI). J Investig Dermatol Symp Proc. 2004 Mar;9(2):169-80. doi: 10.1111/j.1087-0024.2004.09113.x. No abstract available. |
| 17010738 | Background | Gordon KB, Langley RG, Leonardi C, Toth D, Menter MA, Kang S, Heffernan M, Miller B, Hamlin R, Lim L, Zhong J, Hoffman R, Okun MM. Clinical response to adalimumab treatment in patients with moderate to severe psoriasis: double-blind, randomized controlled trial and open-label extension study. J Am Acad Dermatol. 2006 Oct;55(4):598-606. doi: 10.1016/j.jaad.2006.05.027. Epub 2006 Aug 10. |
| 17444593 | Background | Genovese MC, Mease PJ, Thomson GT, Kivitz AJ, Perdok RJ, Weinberg MA, Medich J, Sasso EH; M02-570 Study Group. Safety and efficacy of adalimumab in treatment of patients with psoriatic arthritis who had failed disease modifying antirheumatic drug therapy. J Rheumatol. 2007 May;34(5):1040-50. Epub 2007 Apr 15. |
| 17305904 | Background | Pitarch G, Sanchez-Carazo JL, Mahiques L, Perez-Ferriols MA, Fortea JM. Treatment of psoriasis with adalimumab. Clin Exp Dermatol. 2007 Jan;32(1):18-22. doi: 10.1111/j.1365-2230.2006.02288.x. |
| 21173304 | Background | Leonardi C, Langley RG, Papp K, Tyring SK, Wasel N, Vender R, Unnebrink K, Gupta SR, Valdecantos WC, Bagel J. Adalimumab for treatment of moderate to severe chronic plaque psoriasis of the hands and feet: efficacy and safety results from REACH, a randomized, placebo-controlled, double-blind trial. Arch Dermatol. 2011 Apr;147(4):429-36. doi: 10.1001/archdermatol.2010.384. Epub 2010 Dec 20. |
| 20953189 | Background | Stuart PE, Nair RP, Ellinghaus E, Ding J, Tejasvi T, Gudjonsson JE, Li Y, Weidinger S, Eberlein B, Gieger C, Wichmann HE, Kunz M, Ike R, Krueger GG, Bowcock AM, Mrowietz U, Lim HW, Voorhees JJ, Abecasis GR, Weichenthal M, Franke A, Rahman P, Gladman DD, Elder JT. Genome-wide association analysis identifies three psoriasis susceptibility loci. Nat Genet. 2010 Nov;42(11):1000-4. doi: 10.1038/ng.693. Epub 2010 Oct 17. |
| 23193625 | Background | Institute of Medicine (US) Standing Committee on the Scientific Evaluation of Dietary Reference Intakes and its Panel on Folate, Other B Vitamins, and Choline. Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline. Washington (DC): National Academies Press (US); 1998. Available from http://www.ncbi.nlm.nih.gov/books/NBK114310/ |
| 20861854 | Background | Suarez-Farinas M, Fuentes-Duculan J, Lowes MA, Krueger JG. Resolved psoriasis lesions retain expression of a subset of disease-related genes. J Invest Dermatol. 2011 Feb;131(2):391-400. doi: 10.1038/jid.2010.280. Epub 2010 Sep 23. |
| hypermagnesemia | View source |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Eleven subjects went for screening: 8 were labelled 'White' though one had an Asian name(From India) and 3 were African American. Three subjects failed screening: two Caucasian: one white, one was the 'white' person with the Asian name and one African American. Of the 8 who were enrolled, 2 were African American and 6 were Caucasian (white). The one enrolled subject who develeoped an SAE before entering the vitamin plus adalimumab part of the study was white. The seven who completed the study: 5 Caucasians and 2 African Americans. | Count of Participants | Participants |
|
| number enrolled participants | Number | participants 8 |
|
| Adult patients with plaque psoriasis >10% BSA | Number | participants |
|
|
|
| Secondary | Number of Participants With a Categorical DLQI (Dermatology Life Quality Index) Change | DLQI is 10 questions examining impact of skin disease on quality of life: (1) symptoms & feelings (2) daily activities (3) leisure (4) work & school (5) personal relationship (6) treatment. To be administered to adults over 18 years with moderate to severe plaque psoriasis at week 0 (no systemic psoriasis medication);. weeks 16 ( after 16 weeks of adalimumab) and week 28 (after 16 weeks adalimumab then 12 weeks of adalimumab plus daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12). | 8 adults with moderate to severe plaque psoriasis measured at weeks 16 and 28. Seven were measured weeks 16 and 28. One had SAE prior to week 16. | Posted | Number | participants | Week 16 and Week 28 |
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|
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| Other Pre-specified | Number of Participants in the Categories of Having and Not Having an Adverse Event | Worsening psoriasis or development or worsening of measured condition or new pathology not seen by week 16 but developed at weeks 28 or first discoved by telephone call day 70 post study: AE Humira only | 8 adult participants ages 18-65 with moderate to severe plaque psoriasis. Seven assessed after week 16 and at Week 28 of study and assessed at day 70 post week 28 visit ( the latter by telephone). One subject had SAE prior to vitamin addition. | Posted | Number | participants | After Week 16 of study |
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|
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| Other Pre-specified | Number of Participants in the Categories of Having and of Not Having a Serious Adverse Event (SAE) | A serious adverse event is hosptalization or death or pathology leading to early termination of a participant from the study. This was to be reported at anytime during the 28 week study of adult patients ages 18-65 with moderate to severe plaque psoriasis though categorized by Week 16 (on adalimumab alone, by Week 28 (on adalimuamb plus 3 B vitaminsand by day 70 post Week 28. | Adults ages 18-65 with moderate to severe plaque psoriasis. | Posted | Number | participants | By Week 16, by Week 28 and by Day 70 post Week 28. |
|
|
|
| Other Pre-specified | Number of Participants in the Categories of Normalizing, Unchanging and Newly Abnormal Electrocardiograms (EKGs) | An electrocardiogram (EKG) is used to evaluate the electrical activity of the heart by converting this activity into line tracings on paper.. Electrodes (small, plastic patches) are placed at certain locations on the chest, arms, and legs. When the electrodes are connected to an EKG machine by lead wires, the electrical activity of the heart is measured, interpreted, and printed out for the doctor's information and further interpretation. This test was to be administered to adults age 18 or older with moderate to severe plaque psoriasis patients at week 0, 16 and week 28 of this study. | 8 adults with moderate to severe plaque psoriasis. Seven evaluated at weeks 0,16 and 28 for no change in electrocardiogram (EKG) , worsening arrhymia or improvement of arrhythmia at weeks 16 and 28. Five of 8 studied weeks 0,16 and 28; 1 at week 16 and 28. Two (one with the SAE prior to Week 16) did not have EKGs both at weeks 16 and 28. | Posted | Number | participants | Week 16 and then Week 28 after another 12 weeks on Humira plus vitamins and if early termination |
|
|
|
| Secondary | Number of Participants With Category Change in Serum VEGF (Vascular Endothelial Growth Factorl) | Adult particpants ages 18 or older with moderate to severe plaque psoriasis were to have serum VEGF measured at week 0 on no systemic psoriasis medication then at both weeks 16 on adalimumab and at week 28 on adalimumab plus folic acid, B6 and Vitamin B12. Subjects raniked by BMI week 0 low to high | 8 adult subjects age 18-65 with moderate to sefver plaque psoriasis. Five subjects had VEGF levels taken weeks 16 and 28. Three ( one wiht SAE prior to week 16) did not. | Posted | Number | participants | At Screening visit, Week 16 on Humira, after another 12 weeks on Humira plus vitamins and if early termination |
|
|
|
| Other Pre-specified | Number of Participants in Categories or Increasing and Decreasing Changes Within the CBC (Complete Blood Count) | Change in CBC parameter: white blood count or hemoglobin or hematocrit ( as measured week 16 on adalimumab and at week 28 after 12 more weeks on adalimuamb , folic acid, B6 and B12) in adults ages 18-65 with moderate to severe plaque psoriasis. | 8 adult participants with moderate to severe plaque psoriasis. Five had CBCs at both week 16 and week 28. three did not ( one of the 3 had a SAE pripor to week 16) | Posted | Number | participants | Week 16 and Week 28 |
|
|
|
| Other Pre-specified | Number of Participants Within the Categories of Increasing and Decreasing Serum Magnesium | Serum magnesium (Mg) was to be measured at baseline, Week 16 (on adalimumab) and at week 28 (on adalimumab plus folic acid, vitamins B6 and B12) in adult participants age 18 or older with moderate to severe plaque psoriasis. | 8 Adults age 18-65 with moderate to severe plaque psoriasis.Five had results both weeks 16 and 28. Three did npot (of these 1 had SAE prior to week 16) | Posted | Number | participants | Weeks 16 and 28 |
|
|
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| Other Pre-specified | Number of Participants Within the Categories of Increasing and Decreasing Serum Phosphorus | Serum phosphorus (P) levels were to be measured weeks16 and 28 in adult participants age 18 and older with moderate to severe plaque psoriasis at week 0 on no systemic psoriasis medication; week 16 after 16 weeks of adalimumab and at week 28 after 16 weeks of adalimumab plus 12 weeks of adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of B12. | 8 adults 18-65 years having moderate to severe plaque psoriasis. Five had levels measured at week 16 and and again at week 28 . Three did not . Of the 3 1 had SAE prior to week 16. | Posted | Number | participants | Week 16 then Week 28 |
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|
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| Secondary | Number of Participants Within the Categories of Increasing and Decreasing Serum Homocysteine | Serum homocysteine measured at week 16 after 16 weeks of adalimumab and week 28 after 16 weeks of adalimumaband then 12 weeks of adalimumab plus 5 mg folic acid, 100mg B6 and 1000 mcg of B12 in adults ages 18-65 with moderate to sever plaque psoriasis.. | 8 adults 18-65 with moderate to severe plaque psoriasis. 4 had levels measured at Week 16 and again at Week 28. Of the 4 not meausres 1 had a SAE prior to Week16. | Posted | Number | participants | Week 16 and Week 28 |
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|
|
| Secondary | Number of Participants With Category Change in Vitamin B12 Blood Level | Adult participants 18 years or older with moderate to severe plaque psoriasis were to have serum B12 levels measures Weeks 0 (on no systemic psoriasis medication), 16 (on adalimumab) and week 28 (on adalimumab plus daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12. | 8 adult participants ages 18-65 with moderate to severe plaque psoriasis. Five of 8 had B12 measured at weeks 16 and 28. Three did not. One of the 3 had SAE prior to week 16. | Posted | Number | participants | At Week 16 and Week 28 |
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|
|
| Secondary | Number of Participants Within the Categories of Increasing and Decreasing Serum Vitamin B6 Level | Serum vitamin B6 levels were to be measured weeks16 after 16 weeks adalimumab and at week 28 after 16 weeks adalimumab and 12 weeks on adalimuamb, folic acid 5 mg, b6 100 mg and B12 1000 mcg in adult participants with moderate to sever plque psoriasis. | 8 adults 18-65 with moderate to severe plaque psoriasis measured at weeks 16 and 28. .Four of 8 had levels drawn at weeks 16 and 28. Four did not. Of the four whoi did not one had a SAE prior to Week 16. | Posted | Number | participants | At Week 16 and Week 28 |
|
|
|
| Secondary | Number of Participants With Category Change in Serum Folic Acid Level. | Serum folic acid level in adults ages 18 and older with mild to moderate plaque psoriasis measured at week 16 after 16 weeks adalimumab and at week 28 after 16 weeks adalimumab plus 12 weeks of adalimumab and daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12. | 8 particpantts with psoriasis. Five had folic acid levels drawn weeks 16 and 28. Three did not (one of the 3 had a SAE prior to week 16). | Posted | Number | participants | Weeks 16 and 28 |
|
|
|
| Other Pre-specified | Number of Participants Within the Categories of Elevated and Normal Helicobacter Pylori Antibody | Adult participants age 18 years or older with moderate to severe plaque psoriasis with serum IgG antibodies against Helicobacter pylori bacteria using commercial ELISA assay during the 28 week study. | 8 adult participants with moderate to severe plaque psoriasis with H. pylori titers measured during the 28 week study. | Posted | Number | participants | Week 28 after 16 weeks of Adalimumab then 12 of Adalimumab-Vitamins |
|
|
|
| Other Pre-specified | Number of Participants Within the Categories of Positive Urine Pregnancy Test (Urine Hcg) | Women of childbearing years over age 18 with moderate to severe plaque psoriasis on no systemic therapy at week 0 of study. | Only 1 of the 8 subjects was a woman of childbearing years during the study. | Posted | Number | participant | At screening |
|
|
|
| Other Pre-specified | Number of Participants Within the Categories of Increasing and Decreasing Blood Pressure and Pulse Measures: | Blood pressure is the force the heart exerts against the walls of arteries as it pumps the blood out to the body. The unit of measurement is millimeters of mercury (mm Hg). Pulse is the number of times your heart beats per minute. The unit of measurement is beats per minute (BPM). These test measurements compared in adults with moderate to severe plaque psoriasis week 16 after 16 weeks adalimumab and week 28 after 16 weeks adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg vitamin B12. | of 8 adults with moderate to severe plaque psoriasis, Seven participants were measured at week 16 after 16 weeks adalimumab and at week 28 after 16 weeks adalimumab then 12 weeks of adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12. One who had SAE prior to Week 16 did not.. | Posted | Number | participants | Week 16 and Week 28 |
|
|
|
| Other Pre-specified | Number of Participants Within Categories of Body Temperature Change | Using a thermometer for body temperature on degrees Fahrenheit. Participants to be measured were adults 18 years or older with moderate to severe plaque psoriasis with temperature to be measured at week 16 16 weeks of adalimumab and week 28 after 16 weeks of adalimumab then 12 weeks of adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of B12. | 8 Subjects. Five had temperatures measured weeks 16 and 28. Three did not (one of the 3 had SAE prior to week16) | Posted | Number | participants | Weeks 16 and 28 |
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| Other Pre-specified | Number of Participants Who Fulfilled the Category of Having Height Measured | Height is the distance from the bottom (soles of feet ) to the top (top of head) of a person when that person is standing in this study using ruler in inches.Participants measured were adults age 18 or older with moderate to severe plaque psoriasis. | 8 Adults with mild to moderate plaque psoriasis had their height measured at week 0 in inches. | Posted | Number | participants | Week 0 at Start of Adalimumab |
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| Other Pre-specified | Number of Participants Within the Categories of Increasign and Decreasing Body Weight | Weight is how heavy a participant is. Weight in pounds of each study adult participant age 18-65 years with moderate to severe plaque psoriasis measured at weeks 16 and compared to week 28 of study. | 8 adults ages 18-65 with moderate to severe plaque psoriasis. Seven of 8 had weights taken weeks 0,4,16 and 28 allowing week16 and 28 analysis. One had weight taken only at weeks 0 and 4. | Posted | Number | participants | Week 16 and Week 28 |
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| Primary | Number of Particpants With a Categorical PASI (Psoriasis Area and Severity Index) Change | PASI: formula based on body surface areas on head/neck, trunk, both arms & legs with disease quality grading induration, scale and erythema on participants ages 18-65 with moderate to severe plaque psoriasis measured at weeks 16 and 28. | 8 adults ages 18-65 with moderate to severe plaque psoriasis. Seven of 8 had PASI measured at weeks 16 and 28. One had SAE prior to week 16. | Posted | Number | participants | Weeks 16 and 28 |
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| Post-Hoc | PASI Change Related to Baseline Body Mass Index Above, Below and Equal to 27.3 | Change in PASI from Week 16 on adalimumab to Week 28 on adalimumab, folic acid, vitamin B6 and B12 in adults ages 18-65 with moderate to severe plaque psoriasis. | 8 Adult subjects ages 18-65 with moderate to severe plaque psoriasis. 7 had PASI data both Week 16 and Week 28. The 1 who did not had SAE prior to Week 16. | Posted | Number | participants | Week 16 and Week 28 |
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| Post-Hoc | PASI Change in Participants With Baseline VEGF Above 140 pg/ml and in Participants With Normal Baseline VEGF | Baseline VEGF level at week zero related to PASI change Week 16 on adalimumab compared to Week 28 after additonal 12 weeks of adalimumab plus folic acid, vitamin B6 and B12 in adult psoriasis patients ages 18-65 with moderate to severe plaque psoriasis.High levels were greater than or equal to 140 pg/ml. Normal VEGF was below this level. | 8 adult participants with moderate to severe plaque psoriasis ages 18 to 65. Seven were analyzed. The one not analyzed had SAE prior to week16. | Posted | Number | participants | Week 16 and Week 28 |
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| Post-Hoc | Psoriasis Change in Participants With High H. Pylori Titers and With Normal Titers. | Change in PASI from Week 16 after 16 weeks of adalimumab to Week 28 after another 12 weeks of adalimumab plus folic acid, vitamins B6 and B12 and Change reported by telephone 70 days after week 28 | 8 Adults ages 18-65 with moderate tosevere plaque psoriasis. 7 subjects studied. The 8th had SAE prior to Week 16. | Posted | Number | participants | Week 16 to Week 28 and Week 28 to post study day 70 |
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| Post-Hoc | EKG Categoryy Changes Related to Homocysteine Changes | Change in EKG ( normalize, unchanged, became abnormal) when homocysteine (Hcy) increased or decreased from week 16 on adalimumab to week 28 on adalimumab plus folic acid, vitamins B6 and B12 in adault psoriasis patients ages 18-65 with moderate to severe plaque psoriasis. | 8 adults with moderate to severe plaque psoriasis ages 18-65. 4 were studied. Four were not because homocysteine levels at both Week16 nd 28 were not drawn(1 of the 4 had SAE prior to Week 16). | Posted | Number | participants | Week 16 to Week 28 |
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| 1 |
| 8 |
| 3 |
| 7 |
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| psoriasis flare | Skin and subcutaneous tissue disorders | flare | Non-systematic Assessment | 2 subjects' psoriasis worsened by PASI after vitamins added to adalimumab (1 one also by BSA and one also by DLQI) one additional flare noted post study day 70 still on adalimumab. |
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| Elevated White blood count | Blood and lymphatic system disorders | AE and SAE | Non-systematic Assessment | Occurred while on Humira alone in 1 subject. |
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| elevated Helicobacter pyori antibody | Infections and infestations | AE and SAE | Non-systematic Assessment | New elevation after week 0 in 1 subject after vitamins added to Humira |
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| nonspecific st-t wave changes | Cardiac disorders | AE and SAE | Non-systematic Assessment | Occurred in 1 subject on Humira alone. |
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Not provided
Not provided
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010847 | Picolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
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| SAE by Day 70 afterWeek 28 |
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| Title | Measurements |
|---|---|
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| Title | Measurements |
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| Title | Measurements |
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| Hemoglobin/Hematocrit increased |
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| Hemoglobin/Hematocrit unchanged |
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| Hemoglobin/Hematocrit decreased |
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| Title | Measurements |
|---|
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| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
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| Not evaluable (if >20 ng/ml only stated as such) |
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| Title | Measurements |
|---|---|
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| Diastolic BP increased |
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| Diastolic BP unchanged |
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| Diastolic BP decreased |
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| Pulse increased |
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| Pulse unchanged |
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| Pulse decreased |
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| Title | Measurements |
|---|
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| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
|---|---|
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| BMI<27.3 who improved |
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| BMI<27.3 who worsened |
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| Title | Measurements |
|---|---|
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| PASI Improved with normal VEGF |
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| PASI Worsened with normal VEGF |
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| Title | Measurements |
|---|---|
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| normal titer unchanged then improved day 70 |
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| normal titer worsened |
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| Title | Measurements |
|---|---|
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