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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were 11 potential subjects analyzed of which 3 were not enrolled prior to study assignment. The 3 did not meet study criteria.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Humira Then Humira Plus 3 B Vitamins
STARTED   8 [1] 
COMPLETED   7 [2] 
NOT COMPLETED   1 
Adverse Event                1 
[1] Study was started January 22, 2010
[2] 11 screened 8 entered study 1 terminated.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
5 male 3 female Adults over age 18 < or = 65 7 Adults over age 65 1

Reporting Groups
  Description
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


Baseline Measures
   Humira Then Humira Plus 3 B Vitamins 
Overall Participants Analyzed 
[Units: Participants]
 8 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   7 
>=65 years   1 
Gender 
[Units: Participants]
 
Female   3 
Male   5 
Race (NIH/OMB) [1] 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   2 
White   6 
More than one race   0 
Unknown or Not Reported   0 
[1]

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 
[Units: Participants 8]
 8 
Adult patients with plaque psoriasis >10% BSA 
[Units: Participants]
 
Male   5 
Female   3 


  Outcome Measures

1.  Primary:   Number of Particpants With a Categorical PASI (Psoriasis Area and Severity Index) Change   [ Time Frame: Weeks 16 and 28 ]

2.  Secondary:   Number of Participants With a Categorical Change in Static Physician Global Assessment (sPGA):   [ Time Frame: Week 16 and Week 28 ]

3.  Secondary:   Number of Participants With a Categorical DLQI (Dermatology Life Quality Index) Change   [ Time Frame: Week 16 and Week 28 ]

4.  Secondary:   Number of Participants With Category Change in Serum VEGF (Vascular Endothelial Growth Factorl)   [ Time Frame: At Screening visit, Week 16 on Humira, after another 12 weeks on Humira plus vitamins and if early termination ]

5.  Secondary:   Number of Participants Within the Categories of Increasing and Decreasing Serum Homocysteine   [ Time Frame: Week 16 and Week 28 ]

6.  Secondary:   Number of Participants With Category Change in Vitamin B12 Blood Level   [ Time Frame: At Week 16 and Week 28 ]

7.  Secondary:   Number of Participants Within the Categories of Increasing and Decreasing Serum Vitamin B6 Level   [ Time Frame: At Week 16 and Week 28 ]

8.  Secondary:   Number of Participants With Category Change in Serum Folic Acid Level.   [ Time Frame: Weeks 16 and 28 ]

9.  Other Pre-specified:   Number of Participants in the Categories of Having and Not Having an Adverse Event   [ Time Frame: After Week 16 of study ]

10.  Other Pre-specified:   Number of Participants in the Categories of Having and of Not Having a Serious Adverse Event (SAE)   [ Time Frame: By Week 16, by Week 28 and by Day 70 post Week 28. ]

11.  Other Pre-specified:   Number of Participants in the Categories of Normalizing, Unchanging and Newly Abnormal Electrocardiograms (EKGs)   [ Time Frame: Week 16 and then Week 28 after another 12 weeks on Humira plus vitamins and if early termination ]

12.  Other Pre-specified:   Number of Participants in Categories or Increasing and Decreasing Changes Within the CBC (Complete Blood Count)   [ Time Frame: Week 16 and Week 28 ]

13.  Other Pre-specified:   Number of Participants Within the Categories of Increasing and Decreasing Serum Magnesium   [ Time Frame: Weeks 16 and 28 ]

14.  Other Pre-specified:   Number of Participants Within the Categories of Increasing and Decreasing Serum Phosphorus   [ Time Frame: Week 16 then Week 28 ]

15.  Other Pre-specified:   Number of Participants Within the Categories of Elevated and Normal Helicobacter Pylori Antibody   [ Time Frame: Week 28 after 16 weeks of Adalimumab then 12 of Adalimumab-Vitamins ]

16.  Other Pre-specified:   Number of Participants Within the Categories of Positive Urine Pregnancy Test (Urine Hcg)   [ Time Frame: At screening ]

17.  Other Pre-specified:   Number of Participants Within the Categories of Increasing and Decreasing Blood Pressure and Pulse Measures:   [ Time Frame: Week 16 and Week 28 ]

18.  Other Pre-specified:   Number of Participants Within Categories of Body Temperature Change   [ Time Frame: Weeks 16 and 28 ]

19.  Other Pre-specified:   Number of Participants Who Fulfilled the Category of Having Height Measured   [ Time Frame: Week 0 at Start of Adalimumab ]

20.  Other Pre-specified:   Number of Participants Within the Categories of Increasign and Decreasing Body Weight   [ Time Frame: Week 16 and Week 28 ]

21.  Post-Hoc:   PASI Change Related to Baseline Body Mass Index Above, Below and Equal to 27.3   [ Time Frame: Week 16 and Week 28 ]

22.  Post-Hoc:   PASI Change in Participants With Baseline VEGF Above 140 pg/ml and in Participants With Normal Baseline VEGF   [ Time Frame: Week 16 and Week 28 ]

23.  Post-Hoc:   Psoriasis Change in Participants With High H. Pylori Titers and With Normal Titers.   [ Time Frame: Week 16 to Week 28 and Week 28 to post study day 70 ]

24.  Post-Hoc:   EKG Categoryy Changes Related to Homocysteine Changes   [ Time Frame: Week 16 to Week 28 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination due to high amount of combination of side effects and poor outcomes leading to small numbers of subjects analyzed.


  More Information

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
e-mail: paronson@med.wayne.edu


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