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

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ClinicalTrials.gov Identifier: NCT01704599
Recruitment Status : Terminated (side effect and poor clinical outcome)
First Posted : October 11, 2012
Results First Posted : February 4, 2015
Last Update Posted : February 4, 2015
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Peter J. Aronson, MD, Wayne State University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Psoriasis
Intervention Drug: Humira Then Humira plus 3 B vitamins
Enrollment 8
Recruitment Details All subjects were recruited at one of the Two Wayne State University Physician Group Dermatology clinics . Recruitment began Oct 2010 and lasted until 2012
Pre-assignment Details There were 11 potential subjects analyzed of which 3 were not enrolled prior to study assignment. The 3 did not meet study criteria.
Arm/Group Title Humira Then Humira Plus 3 B Vitamins
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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

Period Title: Overall Study
Started 8 [1]
Completed 7 [2]
Not Completed 1
Reason Not Completed
Adverse Event             1
[1]
Study was started January 22, 2010
[2]
11 screened 8 entered study 1 terminated.
Arm/Group Title Humira Then Humira Plus 3 B Vitamins
Hide Arm/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.

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

Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
5 male 3 female Adults over age 18 < or = 65 7 Adults over age 65 1
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
  87.5%
>=65 years
1
  12.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
3
  37.5%
Male
5
  62.5%
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
  25.0%
White
6
  75.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
[1]
Measure Description:

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.

number enrolled participants  
Measure Type: Number
Unit of measure:  Participants 8
Number Analyzed 8 participants
8
Adult patients with plaque psoriasis >10% BSA  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 8 participants
Male 5
Female 3
1.Primary Outcome
Title Number of Particpants With a Categorical PASI (Psoriasis Area and Severity Index) Change
Hide Description 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.
Time Frame Weeks 16 and 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Humira Then Humira Plus 3 B Vitamins
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8 adults ages 18-65 with moderate to severe plaque psoriasis with PASI measured week 0 on no systemic psoriasis medication, weeks 4 and 16 after 4 and 16 weeks of adalimumab and week 28 after 16 weeks of adalimumab plus 12 weeks of adalimumab and 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of B12 ranked by calculated Body Mass Index (BMI) week 0.
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: participants
Improved 4
Unchanged 1
Worsened 2
2.Secondary Outcome
Title Number of Participants With a Categorical Change in Static Physician Global Assessment (sPGA):
Hide Description 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.
Time Frame Week 16 and Week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Humira Then Humira Plus 3 B Vitamins
Hide Arm/Group Description:
Adults ages 18-65 with moderate to severe plaque psoriasis measured at week 16 after 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.
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: participants
Improved 3
Unchanged 1
Worsened 3
3.Secondary Outcome
Title Number of Participants With a Categorical DLQI (Dermatology Life Quality Index) Change
Hide Description 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).
Time Frame Week 16 and Week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Humira Then Humira Plus 3 B Vitamins
Hide Arm/Group Description:
Adults ages 18-65 years with moderate to severe plaque psoriasis evaluated at week 0 on no systemic psoriasis medication; weeks 16 after 16 weeks adalimumab and 28 after 16 weeks adalimumab then 12 weeks adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12.
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: participants
Improved 3
Unchanged 3
Worsened 1
4.Secondary Outcome
Title Number of Participants With Category Change in Serum VEGF (Vascular Endothelial Growth Factorl)
Hide Description 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
Time Frame At Screening visit, Week 16 on Humira, after another 12 weeks on Humira plus vitamins and if early termination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Humira Then Humira Plus 3 B Vitamins
Hide Arm/Group Description:
Adults ages 18-65 with moderate to severe plaque psoriasis with subject serum levels to be measured weeks 16 after 16 weeks of adalimumab and week 28 after 16 weeks of adalimumab and then 12 weeks of adalimumab plus daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of vitamin B12.
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
Increased 4
Unchanged 0
Decreased 1
5.Secondary Outcome
Title Number of Participants Within the Categories of Increasing and Decreasing Serum Homocysteine
Hide Description 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..
Time Frame Week 16 and Week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Humira Plus 3 B Vitamins
Hide Arm/Group Description:
adults 18-65 with plaque psoriasis (moderate to severe) measured at week 0 on no systemic psoriasis medication; week 16 after 16 weeks adalimumab and at 28 weeks after 16 weeks adalimumab plus 12 weeks folic acid, vitamin B6 and B12.
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: participants
Increased 1
Unchanged 0
Decreased 3
6.Secondary Outcome
Title Number of Participants With Category Change in Vitamin B12 Blood Level
Hide Description 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.
Time Frame At Week 16 and Week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Humira Then Humira Plus 3 B Vitamins
Hide Arm/Group Description:
Adults ages 18-65 with moderate to severe plaque psoriasis.
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
Increased 5
Unchanged 0
Worsened 0
7.Secondary Outcome
Title Number of Participants Within the Categories of Increasing and Decreasing Serum Vitamin B6 Level
Hide Description 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.
Time Frame At Week 16 and Week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Humira Then Humira Plus 3 B Vitamins
Hide Arm/Group Description:
Adults 18-65 years with moderate to severe plaque psoriasis measured at week 16 after 16 weeks adalimumab and week 28 after 28 weeks adalimumab annd 12 weeks on adalimumab, folic acid 5 mg, 100 mg B6 and 1000 mcg B12.
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: participants
Increased 4
Unchanged 0
Decreased 0
8.Secondary Outcome
Title Number of Participants With Category Change in Serum Folic Acid Level.
Hide Description 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.
Time Frame Weeks 16 and 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Humira Then Humira Plus 3 B Vitamins
Hide Arm/Group Description:
Adults ages 18-65 with moderate to severe plaque psoriasis measured at 16 after 16 weeks of adalimumab and week 28 after 16 weeks of adalimumab then 12 weeks of adalimumab and daily 5 mg folic acid 100 mg vitamin B6 and 1000 mcg B12.
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
Increased 3
Unchanged 0
Decreased 0
Not evaluable (if >20 ng/ml only stated as such) 2
9.Other Pre-specified Outcome
Title Number of Participants in the Categories of Having and Not Having an Adverse Event
Hide Description

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

Time Frame After Week 16 of study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Humira Then Humira Plus 3 B Vitamins
Hide Arm/Group Description:
Adults ages 18-65 with moderate to severe plaque psoriasis evaluated at after week 16 of study on or after of adalimumab then 12 weeks of adalimumab plus daily 5 mg folic acid, 100 mg vitamin B6 and vitamin B12 or during the 10 weeks after that.
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: participants
No Adverse Event after Week 16 2
Adverse Event Weeks 16-28 4
Adverse event by Day 70 call after Week 28 1
10.Other Pre-specified Outcome
Title Number of Participants in the Categories of Having and of Not Having a Serious Adverse Event (SAE)
Hide Description 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.
Time Frame By Week 16, by Week 28 and by Day 70 post Week 28.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Adults ages 18-65 with moderate to severe plaque psoriasis.
Arm/Group Title Humira Then Humira Plus 3 B Vitamins
Hide Arm/Group Description:
Adult 18-65 year old adults with moderate to severe plaque psoriasis with adverse event documented sometime during the 28 week study plus telephone call day 70 post week 28 visit either with knowledge of serious event of adverse event documented from data taken weeks 4 and 16 on adalimumab alone and week 28 after 16 weeks on adalimumab plus 12 weeks on adalimumab and daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12 and a telephone call day 70 post week 28 study visit and a telephone call day 70 post week 28 visit.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: participants
No SAE 7
SAE by Week 16 1
SAE by Week 28 0
SAE by Day 70 afterWeek 28 0
11.Other Pre-specified Outcome
Title Number of Participants in the Categories of Normalizing, Unchanging and Newly Abnormal Electrocardiograms (EKGs)
Hide Description 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.
Time Frame Week 16 and then Week 28 after another 12 weeks on Humira plus vitamins and if early termination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Humira Then Humira Plus 3 B Vitamins
Hide Arm/Group Description:
Adults ages 18-65 years with moderate to severe plaque psoriasis measured at week 0 on no systemic psoriasis medication; week 16 on adalimumab for 16 weeks and then 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.
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
Normalizing 1
Unchanged 4
Newly abnormal 1
12.Other Pre-specified Outcome
Title Number of Participants in Categories or Increasing and Decreasing Changes Within the CBC (Complete Blood Count)
Hide Description 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.
Time Frame Week 16 and Week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Humira Then Humira Plus 3 B Vitamins
Hide Arm/Group Description:
Adult subjects ages 18-65 with moderate to severe plaque psoriasis measured at week 0 on no systemic psoriasis medication ,week 16 after 16 wqeeks of adalimumab and week 28 after 16 weeks of adalimumab then 12 weeks of adalimumab plus folic acid 5 mg. vitamin B6 100 mg and vitamin B12 1000 mcg daily assessing CBC with diferential for increase, decrease and no change.
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
WBC increased 3
WBC unchanged 0
WBC decreased 2
Hemoglobin/Hematocrit increased 3
Hemoglobin/Hematocrit unchanged 0
Hemoglobin/Hematocrit decreased 2
13.Other Pre-specified Outcome
Title Number of Participants Within the Categories of Increasing and Decreasing Serum Magnesium
Hide Description 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.
Time Frame Weeks 16 and 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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)
Arm/Group Title Humira Then Humira Plus 3 B Vitamins
Hide Arm/Group Description:
8 adult 18-65 year old moderate to severe plaque psoriasis patients with levels measured weeks 0,16 and 28 in 4 subjects; weeks 0 and 16 in one subject, weeks 16 and 28 in one subject and week 0 only in 2 subjects.
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
Increased 1
Unchanged 2
Decreased 2
14.Other Pre-specified Outcome
Title Number of Participants Within the Categories of Increasing and Decreasing Serum Phosphorus
Hide Description 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.
Time Frame Week 16 then Week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Humira Then Humira Plus 3 B Vitamins
Hide Arm/Group Description:
Adults 18-65 all with moderate to severe plaque psoriasis. Week 0 (on no systemic psoriasis medication), Week 16 ( 16 weeks adalimumab), Week 28 ( 16 weeks on adalimumab plus 12 weeks on adalimumab plus 5 mg folic acid, 100 mg B6 and 1000 mcg B12 daily.
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
Increased 3
Unchanged 0
Decreased 2
15.Other Pre-specified Outcome
Title Number of Participants Within the Categories of Elevated and Normal Helicobacter Pylori Antibody
Hide Description 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.
Time Frame Week 28 after 16 weeks of Adalimumab then 12 of Adalimumab-Vitamins
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
8 adult participants with moderate to severe plaque psoriasis with H. pylori titers measured during the 28 week study.
Arm/Group Title Humira Then Humira Plus 3 B Vitamins
Hide Arm/Group Description:
8 adults ages18-65 with moderate to severe plaque psoriasis tested at week 0 on no systemic psoriasis therapy; week 16 after 16 weeks of adalimumab and week 28 after 16 weeks adalimumab plus 5 mg folic acid, 100 mg B6 and 1000 mcg B12.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: participants
Elevated 2
Normal 6
16.Other Pre-specified Outcome
Title Number of Participants Within the Categories of Positive Urine Pregnancy Test (Urine Hcg)
Hide Description Women of childbearing years over age 18 with moderate to severe plaque psoriasis on no systemic therapy at week 0 of study.
Time Frame At screening
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only 1 of the 8 subjects was a woman of childbearing years during the study.
Arm/Group Title Humira Then Humira Plus 3 B Vitamins
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One adult psoriasis subject age 23 with moderate to severe plaque psoriasis with pregnanacy test on enrollment on no systemic psoriasis therapy.
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: participant
Negative 1
Positive 0
17.Other Pre-specified Outcome
Title Number of Participants Within the Categories of Increasing and Decreasing Blood Pressure and Pulse Measures:
Hide Description 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.
Time Frame Week 16 and Week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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..
Arm/Group Title Humira Then Humira Plus 3 B Vitamins
Hide Arm/Group Description:
Subjects were adults with moderate to severe plaque psoriasis with test to be measured week 0 on no systemic psoriasis medication, 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 of vitamin B12.
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: participants
Systolic BP increased 4
Systolic BP unchanged 0
Systolic BP decreased 3
Diastolic BP increased 5
Diastolic BP unchanged 0
Diastolic BP decreased 2
Pulse increased 5
Pulse unchanged 0
Pulse decreased 2
18.Other Pre-specified Outcome
Title Number of Participants Within Categories of Body Temperature Change
Hide Description 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.
Time Frame Weeks 16 and 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
8 Subjects. Five had temperatures measured weeks 16 and 28. Three did not (one of the 3 had SAE prior to week16)
Arm/Group Title Humira Then Humira Plus 3 B Vitamins
Hide Arm/Group Description:
Temperature measurements in adults ages 18-65 with moderate to severe plaque psoriasis at week16 on adalimuamb and week 28 temperatures on adalimumab and daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12.
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
increased 2
unchanged 2
decreased 1
19.Other Pre-specified Outcome
Title Number of Participants Who Fulfilled the Category of Having Height Measured
Hide Description 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.
Time Frame Week 0 at Start of Adalimumab
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
8 Adults with mild to moderate plaque psoriasis had their height measured at week 0 in inches.
Arm/Group Title Humira Then Humira Plus 3 B Vitamins
Hide Arm/Group Description:
8 adults age 18-65 yearswith moderate to severe plaque psoriasis measured at week 0 of study on no systemic psoriasis medication.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: participants
Measured 8
Not measured 0
20.Other Pre-specified Outcome
Title Number of Participants Within the Categories of Increasign and Decreasing Body Weight
Hide Description 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.
Time Frame Week 16 and Week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Humira Then Humira Plus 3 B Vitamins
Hide Arm/Group Description:
Adults ages 18-65 years with moderate to severe plaque psoriasis. Weight measurement were in pounds measured at Weeks 16 and 28.
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: participants
Increased 2
Unchanged 0
Decreased 5
21.Post-Hoc Outcome
Title PASI Change Related to Baseline Body Mass Index Above, Below and Equal to 27.3
Hide Description 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.
Time Frame Week 16 and Week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Humira Then Humira Plus 3 B Vitamins
Hide Arm/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.

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

Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: participants
BMI >27.3 who improved 4
BMI >27.3 who worsened 0
BMI of 27.3 who were unchanged 0
BMI<27.3 who improved 0
BMI<27.3 who worsened 2
22.Post-Hoc Outcome
Title PASI Change in Participants With Baseline VEGF Above 140 pg/ml and in Participants With Normal Baseline VEGF
Hide Description 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.
Time Frame Week 16 and Week 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Humira Then Humira Plus 3 B Vitamins
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: participants
PASI improved with high VEGF 1
PASI Worsened with high VEGF 2
PASI Unchanged with normal VEGF 1
PASI Improved with normal VEGF 3
PASI Worsened with normal VEGF 0
23.Post-Hoc Outcome
Title Psoriasis Change in Participants With High H. Pylori Titers and With Normal Titers.
Hide Description 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
Time Frame Week 16 to Week 28 and Week 28 to post study day 70
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Hide Analysis Population Description
8 Adults ages 18-65 with moderate tosevere plaque psoriasis. 7 subjects studied. The 8th had SAE prior to Week 16.
Arm/Group Title Humira Then Humira Plus 3 B Vitamins
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: participants
high titer worsened 1
high titer improved then worsened day 70 1
normal titer improved 3
normal titer unchanged then improved day 70 1
normal titer worsened 1
24.Post-Hoc Outcome
Title EKG Categoryy Changes Related to Homocysteine Changes
Hide Description 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.
Time Frame Week 16 to Week 28
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Hide Analysis Population Description
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).
Arm/Group Title Humira Then Humira Plus 3 B Vitamins
Hide Arm/Group Description:

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 (week 28).

Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: participants
normalize when Hcy increased 1
unchanged when Hcy decreased 2
became abnormal when Hcy decreased 1
Time Frame 2010-2013
Adverse Event Reporting Description On Humira alone: WBC elevation, Non specific st-t wave change and Left axis deviation. .
 
Arm/Group Title Humira Then Humira Plus 3 B Vitamins
Hide Arm/Group Description Pneumonia while on adaimumab and before the adalimumab plus B vitamins were begun.prior to vitamins
All-Cause Mortality
Humira Then Humira Plus 3 B Vitamins
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Humira Then Humira Plus 3 B Vitamins
Affected / at Risk (%) # Events
Total   1/8 (12.50%)    
Infections and infestations   
Pneumonia * 1 [1]  1/8 (12.50%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, SAE
[1]
Pneumonia while on adalimumab before vitamins.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Humira Then Humira Plus 3 B Vitamins
Affected / at Risk (%) # Events
Total   3/7 (42.86%)    
Blood and lymphatic system disorders   
Elevated White blood count * 3 [1]  1/7 (14.29%)  1
Cardiac disorders   
left axis deviation * 1 [2]  2/7 (28.57%)  2
nonspecific st-t wave changes * 3 [3]  1/7 (14.29%)  1
Infections and infestations   
elevated Helicobacter pyori antibody * 3 [4]  1/7 (14.29%)  1
Skin and subcutaneous tissue disorders   
psoriasis flare * 2 [5]  3/7 (42.86%)  3
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Arrthymia
2
Term from vocabulary, flare
3
Term from vocabulary, AE and SAE
[1]
Occurred while on Humira alone in 1 subject.
[2]
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)
[3]
Occurred in 1 subject on Humira alone.
[4]
New elevation after week 0 in 1 subject after vitamins added to Humira
[5]
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.
Early termination due to high amount of combination of side effects and poor outcomes leading to small numbers of subjects analyzed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Peter J. Aronson, MD
Organization: Dept. Dermatology Wayne StateUniversity
Phone: (313)_745-7845
Publications:
Standing Committee on the Scientific Evaluation of Dietary Reference Intakes of the Food and Nutrition Board, Institute of Medicine, National Academy of Sciences. Dietary reference intakes for thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B12, pantothenic acid, biotin, and choline. Washington, DC: National Academy Press; 1998.
Responsible Party: Peter J. Aronson, MD, Wayne State University
ClinicalTrials.gov Identifier: NCT01704599     History of Changes
Other Study ID Numbers: Dermatology 1104009591
First Submitted: October 3, 2012
First Posted: October 11, 2012
Results First Submitted: December 8, 2014
Results First Posted: February 4, 2015
Last Update Posted: February 4, 2015