EDCR Study - Etanercept Diamyd Combination Regimen -Open Trial to Evaluate Safety in Children With Type 1 Diabetes

• Sponsor: Johnny Ludvigsson (Other)
• Overall Status: Completed
• CT.gov ID: NCT02464033
• Collaborator: Swedish Child Diabetes Foundation (Other), Ostergotland County Council, Sweden (Other), Diamyd Medical AB (Industry)
• Enrollment: 20
• Locations: 8
• Arm: 1
• Duration (Months): 45.9
• Patients Per Site: 2.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The objectives of this study is to:

• Evaluate the tolerability of a combination therapy with Diamyd, vitamin D and etanercept

• Evaluate how the above mentioned treatments influence the immune system and endogenous insulin secretion

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 1	Drug: GAD-Alum; Drug: Vitamin D; Drug: Etanercept	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open Label Trial to Evaluate the Tolerability of a Combination Therapy Consisting of GAD-alum (Diamyd®), Etanercept and Vitamin D in Children and Adolescents Newly Diagnosed With Type 1 Diabetes
• Study Start Date: May 1, 2015
• Actual Primary Completion Date: Feb 25, 2019
• Actual Study Completion Date: Feb 25, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A All patients will from Day 1 receive 2 000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60.	Drug: GAD-Alum; Recombinant Human Glutamic Acid Decarboxylase (rhGAD65); Other Names: Diamyd ; Drug: Vitamin D; Other Names: Cholecalciferol ; Drug: Etanercept

Outcome Measures

Primary Outcome Measures

1. Number of Patients With Reactions of the Injection Site as an Assessment of the Tolerability [1 months]

   Number of patients with reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching, Other). Inspection of injection site 60 minutes after GAD-Alum injection by investigator or nurse

2. Number of Patients With Reactions of the Injection Site as an Assessment of the Tolerability [2 months]

   Number of patients with reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching, Other). Inspection of injection site 60 minutes after GAD-Alum injection by investigator or nurse

3. Number of Patients With Any Abnormal Findings From Physical Examinations After Baseline [Month 1, 2, 3, 6, 9, 15 and 30]

   Number of patients with any abnormal findings from physical examinations after baseline, including neurological assessments as an assessment of tolerability.

4. Number of Patients With Clinically Significant Laboratory Findings [Month 1, 2, 3, 6, 9, 15 and 30]

   Number of patients with clinically significant laboratory findings, laboratory measurements as an assessment of the tolerability

5. GAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period) [6 months]

   GAD65AB titer (GADA) change from baseline. GAD65AB = Antibodies to GAD with molecular mass 65000

6. GAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period) [15 months]

   GAD65AB titer (GADA) change from baseline. GAD65AB = Antibodies to GAD with molecular mass 65000

7. GAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period) [30 months]

   GAD65AB titer (GADA) change from baseline. GAD65AB = Antibodies to GAD with molecular mass 65000

8. Number of Patients With an Infection Reported as Adverse Event Related to Study Treatment [Month 1, 2, 3, 6, 9, 15 and 30]

   Number of patients with an infection reported as Adverse Event related to study treatment (GAD-Alum and/or Etanercept),as an assessment of the tolerability

Secondary Outcome Measures

1. C-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From Baseline [Baseline and 6 months at 0, 30, 60, 90 and 120 minutes post-dose]

   Weighted mean C-peptide: (AUC mean 0-120 min) during an MMTT, change from baseline to 6 months. MMTT=Mixed Meal Tolerance Test

2. C-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From Baseline [Baseline and 15 months at 0, 30, 60, 90 and 120 minutes post-dose]

   Weighted mean C-peptide: (AUC mean 0-120 min) during an MMTT, change from baseline to 15 months

3. C-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From Baseline [Baseline and 30 months at 0, 30, 60, 90 and 120 minutes post-dose]

   Weighted mean C-peptide: (AUC mean 0-120 min) during an MMTT, change from baseline to 30 months

4. Number of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L [6 months]

   Number of patients with a stimulated maximum C-peptide level above 0.2 nmol/L at 6 months

5. Number of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L [15 months]

   Number of patients with a stimulated maximum C-peptide level above 0.2 nmol/L at 15 months

6. Number of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L [30 months]

   Number of patients with a stimulated maximum C-peptide level above 0.2 nmol/L at 30 months

7. Hemoglobin A1c (HbA1c), Change From Baseline [Baseline and 6 months]

   Hemoglobin A1c (HbA1c), change from baseline to 6 months

8. Hemoglobin A1c (HbA1c), Change From Baseline [Baseline and 15 months]

   Hemoglobin A1c (HbA1c), change from baseline to 15 months

9. Hemoglobin A1c (HbA1c), Change From Baseline [Baseline and 30 months]

   Hemoglobin A1c (HbA1c), change from baseline to 30 months

10. Exogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From Baseline [Baseline and 6 months]

    Exogenous 24-hour insulin dose per kg body weight and 24 hours average, change from baseline

11. Exogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From Baseline [Baseline and 15 months]

    Exogenous 24-hour insulin dose per kg body weight and 24 hours average, change from baseline

12. Exogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From Baseline [Baseline and 30 months]

    Exogenous 24-hour insulin dose per kg body weight and 24 hours average, change from baseline

13. C-peptide: Stimulated, 90 Minute Value, Change From Baseline [Baseline and 6 months]

    C-peptide: Stimulated, 90 minute value, change from baseline to 6 months

14. C-peptide: Stimulated, 90 Minute Value, Change From Baseline [Baseline and 15 months]

    C-peptide: Stimulated, 90 minute value, change from baseline to 15 months

15. C-peptide: Stimulated, 90 Minute Value, Change From Baseline [Baseline and 30 months]

    C-peptide: Stimulated, 90 minute value, change from baseline to 30 months

16. C-peptide Fasting Concentration, Change From Baseline [Baseline and 6 months]

    C-peptide: Fasting concentration, change from baseline to 6 months

17. C-peptide Fasting Concentration, Change From Baseline [Baseline and 15 months]

    C-peptide: Fasting, concentration, change from baseline to 15 months

18. C-peptide Fasting Concentration, Change From Baseline [Baseline and 30 months]

    C-peptide: Fasting, concentration, change from baseline to 30 months

19. Spontaneous IL-17a Secretion [Baseline, 6 months, 9 months, 15 months and 30 months]

    Spontaneous IL-17a secretion at baseline, 6 months, 9 months, 15 months and 30 months

20. GAD65-induced IL-4 Secretion [Baseline, 6 months, 9 months, 15 months, 30 months]

    GAD65-induced IL-4 secretion at baseline, 6 months, 9 months, 15 months, 30 months

21. GAD65-induced IL-13 Secretion [Baseline, 6 months, 9 months, 15 months, 30 months]

    GAD65-induced IL-13 secretion at baseline, 6 months, 9 months, 15 months, 30 months

22. GAD65-induced IFN-gamma Secretion [Baseline, 6 months, 9 months, 15 months, 30 months]

    GAD65-induced IFN-gamma secretion at baseline, 6 months, 9 months, 15 months, 30 months

23. GAD65-induced TNF-alpha Secretion [Baseline, 6 months, 9 months, 15 months, 30 months]

    GAD65-induced TNF-alpha secretion at baseline, 6 months, 9 months, 15 months, 30 months

24. GAD65-induced GM-CSF Secretion [Baseline, 6 months, 9 months, 15 months, 30 months]

    GAD65-induced GM-CSF secretion baseline, 6 months, 9 months, 15 months, 30 months

25. GAD65-induced MIP-1b Secretion [Baseline, 6 months, 9 months, 15 months, 30 months]

    GAD65-induced MIP-1b secretion at baseline, 6 months, 9 months, 15 months, 30 months

26. GAD65-induced MCP-1 Secretion [Baseline, 6 months, 9 months, 15 months, 30 months]

    GAD65-induced MCP-1 secretion at baseline, 6 months, 9 months, 15 months, 30 months

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Informed consent given by patients and parent(s)/legal guardian(s)

2. Type 1 diabetes according to the ADA classification, diagnosed within the previous 100 days at the time of screening

3. Age 8.00 -17.99 years at time of screening

4. Fasting C-peptide at time of screening ≥0.12 nmol/L

5. Positive for GADA but < 50 000 Units

6. Menarchal females must agree to avoid pregnancy and have a negative urine pregnancy test

7. Immunity against Varicella, either through previous infection or vaccination

8. Patients must follow the Swedish vaccination programme

9. Patients of childbearing potential must agree to using adequate contraception, if sexually active, until 1 year after the last administration of GAD-alum and etanercept. Adequate contraception is as follows:

For females of childbearing potential:

1. oral (except low-dose gestagen (lynestrenol and norethisterone), injectable, or implanted hormonal contraceptives (females)

2. intrauterine device (females)

3. intrauterine system (for example, progestin-releasing coil) (females)

4. vasectomized male (with appropriate postvasectomy documentation of the absence of sperm in the ejaculate)

For males of childbearing potential:

1. Condom (male)

Exclusion Criteria:

1. Previous or current treatment with immunosuppressant therapy (although topical or inhaled steroids are accepted)

2. Continuous treatment with anti-inflammatory drug (sporadic treatment e.g. because of headache or in connection with fever a few days will be accepted)

3. Treatment with any oral or injected anti-diabetic medications (especially hypoglycemic agents) other than insulin

4. Treatment with Vitamin D, marketed or not, or unwilling to abstain from such medication during the trial

5. A history of hypercalcemia

6. A history of anaemia or significantly abnormal haematology results at screening

7. A history of epilepsy, head trauma or cerebro-vascular accident, or clinical features of continuous motor unit activity in proximal muscles

8. Clinically significant history of acute reaction to vaccines or other drugs in the past

9. Treatment with any vaccine within 4 months prior to planned first administration of GAD-Alum or planned treatment with vaccine up to 4 months after the last injection with GAD-Alum, including influenza vaccine

10. Participation in other clinical trials with a new chemical entity within the previous 3 months

11. Inability or unwillingness to comply with the provisions of this protocol

12. A history of alcohol or drug abuse

13. A significant illness other than diabetes within 2 weeks prior to first dosing

14. Known human immunodeficiency virus (HIV)

15. Prior or active viral hepatitis B or C infection

16. Females who are lactating or pregnant (for females who have started menstruating the possibility of pregnancy must be excluded by urine βHCG on-site within 24 hours prior to the GAD-Alum and etanercept administration, respectively)

17. Males or females not willing to use adequate contraception, if sexually active, until 1 year after the last GAD-Alum and etanercept administration, respectively

18. Presence of associated serious disease or condition, including active skin infections that preclude subcutaneous injection, which in the opinion of the investigator makes the patient non-eligible for the study.

19. Deemed by the investigator not being able to follow instructions and/or follow the study protocol

20. Active infection, including chronic and local infection or a history of previous tendency to serious infections, recent or ongoing uncontrolled bacterial, viral, fungal or other opportunistic infections, or known infection with active EBV or CMV

21. Hypersensitivity to the active substance in Enbrel (etanercept) or other ingredients in Enbrel

22. Active or inactive (latent) tuberculosis (TBC) at screening

23. History of malignancy or significant cardiovascular disease

24. Current or history of leukopenia, anemia and/or thrombocytopenia

25. Liver disease (clinical or hepatic enzymes >3 times the upper limit of normal (ULN))

26. Renal insufficiency (clinical or creatinine >3 times the upper limit of normal (ULN))

27. MS, undefined neurologic condition or known SLE, or anti-nuclear or known doublestranded DNA antibody positivity

28. Arrhythmia

29. Pancreatitis

30. Vitamin D serum levels >100 nmol/L at screening

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Helsingborg Hospital	Helsingborg		Sweden
2	Linköping University Hospital	Linköping		Sweden
3	Lund University Hospital	Lund		Sweden
4	Skåne University Hospital, UMAS	Malmö		Sweden
5	Sachsska, Södersjukhuset	Stockholm		Sweden
6	Uddevalla Hospital	Uddevalla		Sweden
7	Västerås Hospital	Västerås		Sweden
8	Örebro University Hospital	Örebro		Sweden

Sponsors and Collaborators

• Johnny Ludvigsson
• Swedish Child Diabetes Foundation
• Ostergotland County Council, Sweden
• Diamyd Medical AB

Investigators

• Principal Investigator: Johnny Ludvigsson, MD,PhD,Prof, Linkoeping University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 17, 2015

More Information

Publications

None provided.

• Responsible Party: Johnny Ludvigsson, MD, PhD, Professor, Linkoeping University
• ClinicalTrials.gov Identifier: NCT02464033
• Other Study ID Numbers: EDCR IIa
• First Posted: Jun 8, 2015
• Last Update Posted: Mar 29, 2021
• Last Verified: Mar 1, 2021

• Keywords provided by Johnny Ludvigsson, MD, PhD, Professor, Linkoeping University: Diamyd; Diabetes; Juvenile Diabetes; Diabetes Type 1; Type 1 Diabetes; Autoimmune Diabetes; Insulin Dependent Diabetes; Type 1 Diabetes MellitusType 1 Diabetes Mellitus; rhGAD65; GAD65; GAD-Alum; Diabetes Mellitus; Diabetes mellitus Type 1; Glucose Metabolism Disorders; Metabolic Diseases; Vitamin D; Etanercept
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Vitamin D; Cholecalciferol; Etanercept

Study Results

Participant Flow

Arm/Group Title	GAD-Alum+Vitamin D+Etanercept
Arm/Group Description	All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
Period Title: Overall Study
STARTED	20
COMPLETED	20
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	GAD-Alum+Vitamin D+Etanercept
Arm/Group Description	All patients will from Day 1 receive 2 000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
Overall Participants	20
Age (Count of Participants)
<=18 years	20 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	12.36 (2.321)
Sex: Female, Male (Count of Participants)
Female	7 35%
Male	13 65%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Sweden	20 100%
Type 1 Diabetes duration (days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [days]	81.35 (22.091)
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	18.38 (2.141)

Outcome Measures

1. Primary Outcome

Title	Number of Patients With Reactions of the Injection Site as an Assessment of the Tolerability
Description	Number of patients with reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching, Other). Inspection of injection site 60 minutes after GAD-Alum injection by investigator or nurse
Time Frame	1 months

Outcome Measure Data

Analysis Population Description

Safety

Arm/Group Title	GAD-Alum+Vitamin D+Etanercept
Arm/Group Description	All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
Measure Participants	20
Count of Participants [Participants]	3 15%

2. Primary Outcome

Title	Number of Patients With Reactions of the Injection Site as an Assessment of the Tolerability
Description	Number of patients with reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching, Other). Inspection of injection site 60 minutes after GAD-Alum injection by investigator or nurse
Time Frame	2 months

Outcome Measure Data

Analysis Population Description

Safety

Arm/Group Title	GAD-Alum+Vitamin D+Etanercept
Arm/Group Description	All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
Measure Participants	20
Count of Participants [Participants]	5 25%

3. Primary Outcome

Title	Number of Patients With Any Abnormal Findings From Physical Examinations After Baseline
Description	Number of patients with any abnormal findings from physical examinations after baseline, including neurological assessments as an assessment of tolerability.
Time Frame	Month 1, 2, 3, 6, 9, 15 and 30

Outcome Measure Data

Analysis Population Description

Safety

Arm/Group Title	GAD-Alum+Vitamin D+Etanercept
Arm/Group Description	All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
Measure Participants	20
Count of Participants [Participants]	6 30%

4. Primary Outcome

Title	Number of Patients With Clinically Significant Laboratory Findings
Description	Number of patients with clinically significant laboratory findings, laboratory measurements as an assessment of the tolerability
Time Frame	Month 1, 2, 3, 6, 9, 15 and 30

Outcome Measure Data

Analysis Population Description

Safety

Arm/Group Title	GAD-Alum+Vitamin D+Etanercept
Arm/Group Description	All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
Measure Participants	20
Count of Participants [Participants]	0 0%

5. Primary Outcome

Title	GAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period)
Description	GAD65AB titer (GADA) change from baseline. GAD65AB = Antibodies to GAD with molecular mass 65000
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Intention To Treat (ITT)

Arm/Group Title	GAD-Alum+Vitamin D+Etanercept
Arm/Group Description	All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
Measure Participants	20
Mean (Standard Deviation) [U/mL]	2509.41 (4866.515)

6. Primary Outcome

Title	GAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period)
Description	GAD65AB titer (GADA) change from baseline. GAD65AB = Antibodies to GAD with molecular mass 65000
Time Frame	15 months

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	GAD-Alum+Vitamin D+Etanercept
Arm/Group Description	All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
Measure Participants	20
Mean (Standard Deviation) [U/mL]	1036.19 (2527.249)

7. Primary Outcome

Title	GAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period)
Description	GAD65AB titer (GADA) change from baseline. GAD65AB = Antibodies to GAD with molecular mass 65000
Time Frame	30 months

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	GAD-Alum+Vitamin D+Etanercept
Arm/Group Description	All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
Measure Participants	20
Mean (Standard Deviation) [U/mL]	347.01 (1564.466)

8. Primary Outcome

Title	Number of Patients With an Infection Reported as Adverse Event Related to Study Treatment
Description	Number of patients with an infection reported as Adverse Event related to study treatment (GAD-Alum and/or Etanercept),as an assessment of the tolerability
Time Frame	Month 1, 2, 3, 6, 9, 15 and 30

Outcome Measure Data

Analysis Population Description

Safety

Arm/Group Title	GAD-Alum+Vitamin D+Etanercept
Arm/Group Description	All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
Measure Participants	20
Count of Participants [Participants]	3 15%

9. Secondary Outcome

Title	C-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From Baseline
Description	Weighted mean C-peptide: (AUC mean 0-120 min) during an MMTT, change from baseline to 6 months. MMTT=Mixed Meal Tolerance Test
Time Frame	Baseline and 6 months at 0, 30, 60, 90 and 120 minutes post-dose

Outcome Measure Data

Analysis Population Description

ITT, MMTT not performed for 2 patients hence no data available for 2 out of the 20 patients

Arm/Group Title	GAD-Alum+Vitamin D+Etanercept
Arm/Group Description	All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
Measure Participants	18
Mean (Standard Deviation) [nmol/L*min]	-0.09 (0.153)

10. Secondary Outcome

Title	C-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From Baseline
Description	Weighted mean C-peptide: (AUC mean 0-120 min) during an MMTT, change from baseline to 15 months
Time Frame	Baseline and 15 months at 0, 30, 60, 90 and 120 minutes post-dose

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	GAD-Alum+Vitamin D+Etanercept
Arm/Group Description	All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
Measure Participants	20
Mean (Standard Deviation) [nmol/L*min]	-0.30 (0.158)

11. Secondary Outcome

Title	C-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From Baseline
Description	Weighted mean C-peptide: (AUC mean 0-120 min) during an MMTT, change from baseline to 30 months
Time Frame	Baseline and 30 months at 0, 30, 60, 90 and 120 minutes post-dose

Outcome Measure Data

Analysis Population Description

ITT, , MMTT not performed for 1 patient hence no data available for 1 out of the 20 patients

Arm/Group Title	GAD-Alum+Vitamin D+Etanercept
Arm/Group Description	All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
Measure Participants	19
Mean (Standard Deviation) [nmol/L*min]	-0.40 (0.168)

12. Secondary Outcome

Title	Number of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L
Description	Number of patients with a stimulated maximum C-peptide level above 0.2 nmol/L at 6 months
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	GAD-Alum+Vitamin D+Etanercept
Arm/Group Description	All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
Measure Participants	20
Count of Participants [Participants]	17 85%

13. Secondary Outcome

Title	Number of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L
Description	Number of patients with a stimulated maximum C-peptide level above 0.2 nmol/L at 15 months
Time Frame	15 months

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	GAD-Alum+Vitamin D+Etanercept
Arm/Group Description	All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
Measure Participants	20
Count of Participants [Participants]	14 70%

14. Secondary Outcome

Title	Number of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L
Description	Number of patients with a stimulated maximum C-peptide level above 0.2 nmol/L at 30 months
Time Frame	30 months

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	GAD-Alum+Vitamin D+Etanercept
Arm/Group Description	All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
Measure Participants	20
Count of Participants [Participants]	8 40%

15. Secondary Outcome

Title	Hemoglobin A1c (HbA1c), Change From Baseline
Description	Hemoglobin A1c (HbA1c), change from baseline to 6 months
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	GAD-Alum+Vitamin D+Etanercept
Arm/Group Description	All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
Measure Participants	20
Mean (Standard Deviation) [mmol/mol]	0.80 (8.433)

16. Secondary Outcome

Title	Hemoglobin A1c (HbA1c), Change From Baseline
Description	Hemoglobin A1c (HbA1c), change from baseline to 15 months
Time Frame	Baseline and 15 months

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	GAD-Alum+Vitamin D+Etanercept
Arm/Group Description	All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
Measure Participants	20
Mean (Standard Deviation) [mmol/mol]	6.15 (12.495)

17. Secondary Outcome

Title	Hemoglobin A1c (HbA1c), Change From Baseline
Description	Hemoglobin A1c (HbA1c), change from baseline to 30 months
Time Frame	Baseline and 30 months

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	GAD-Alum+Vitamin D+Etanercept
Arm/Group Description	All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
Measure Participants	20
Mean (Standard Deviation) [mmol/mol]	7.55 (11.213)

18. Secondary Outcome

Title	Exogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From Baseline
Description	Exogenous 24-hour insulin dose per kg body weight and 24 hours average, change from baseline
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	GAD-Alum+Vitamin D+Etanercept
Arm/Group Description	All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
Measure Participants	20
Mean (Standard Deviation) [IU]	0.01 (0.249)

19. Secondary Outcome

Title	Exogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From Baseline
Description	Exogenous 24-hour insulin dose per kg body weight and 24 hours average, change from baseline
Time Frame	Baseline and 15 months

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	GAD-Alum+Vitamin D+Etanercept
Arm/Group Description	All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
Measure Participants	20
Mean (Standard Deviation) [IU]	0.25 (0.342)

20. Secondary Outcome

Title	Exogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From Baseline
Description	Exogenous 24-hour insulin dose per kg body weight and 24 hours average, change from baseline
Time Frame	Baseline and 30 months

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	GAD-Alum+Vitamin D+Etanercept
Arm/Group Description	All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
Measure Participants	20
Mean (Standard Deviation) [IU]	0.42 (0.333)

21. Secondary Outcome

Title	C-peptide: Stimulated, 90 Minute Value, Change From Baseline
Description	C-peptide: Stimulated, 90 minute value, change from baseline to 6 months
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

ITT, not performed for 2 patients hence no data available for 2 out of the 20 patients

Arm/Group Title	GAD-Alum+Vitamin D+Etanercept
Arm/Group Description	All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
Measure Participants	18
Mean (Standard Deviation) [nmol/L]	-0.09 (0.233)

22. Secondary Outcome

Title	C-peptide: Stimulated, 90 Minute Value, Change From Baseline
Description	C-peptide: Stimulated, 90 minute value, change from baseline to 15 months
Time Frame	Baseline and 15 months

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	GAD-Alum+Vitamin D+Etanercept
Arm/Group Description	All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
Measure Participants	20
Mean (Standard Deviation) [nmol/L]	-0.35 (0.231)

23. Secondary Outcome

Title	C-peptide: Stimulated, 90 Minute Value, Change From Baseline
Description	C-peptide: Stimulated, 90 minute value, change from baseline to 30 months
Time Frame	Baseline and 30 months

Outcome Measure Data

Analysis Population Description

ITT, not performed for 1 patient hence no data available for 1 out of the 20 patients

Arm/Group Title	GAD-Alum+Vitamin D+Etanercept
Arm/Group Description	All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
Measure Participants	19
Mean (Standard Deviation) [nmol/L]	-0.49 (0.221)

24. Secondary Outcome

Title	C-peptide Fasting Concentration, Change From Baseline
Description	C-peptide: Fasting concentration, change from baseline to 6 months
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	GAD-Alum+Vitamin D+Etanercept
Arm/Group Description	All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
Measure Participants	20
Mean (Standard Deviation) [nmol/L]	-0.02 (0.083)

25. Secondary Outcome

Title	C-peptide Fasting Concentration, Change From Baseline
Description	C-peptide: Fasting, concentration, change from baseline to 15 months
Time Frame	Baseline and 15 months

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	GAD-Alum+Vitamin D+Etanercept
Arm/Group Description	All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
Measure Participants	20
Mean (Standard Deviation) [nmol/L]	-0.10 (0.091)

26. Secondary Outcome

Title	C-peptide Fasting Concentration, Change From Baseline
Description	C-peptide: Fasting, concentration, change from baseline to 30 months
Time Frame	Baseline and 30 months

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	GAD-Alum+Vitamin D+Etanercept
Arm/Group Description	All patients will from Day 1 receive 2000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
Measure Participants	20
Mean (Standard Deviation) [nmol/L]	-0.15 (0.093)

27. Secondary Outcome

Title	Spontaneous IL-17a Secretion
Description	Spontaneous IL-17a secretion at baseline, 6 months, 9 months, 15 months and 30 months
Time Frame	Baseline, 6 months, 9 months, 15 months and 30 months

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	GAD-Alum+Vitamin D+Etanercept
Arm/Group Description	All patients will from Day 1 receive 2 000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
Measure Participants	20
IL-17a, Baseline	3.16 (8.36)
IL-17a, 6 months	6.07 (10.13)
IL-17a, 9 months	7.06 (11.35)
IL-17a,15 months	6.54 (7.83)
IL-17a, 30 months	4.75 (10.64)

28. Secondary Outcome

Title	GAD65-induced IL-4 Secretion
Description	GAD65-induced IL-4 secretion at baseline, 6 months, 9 months, 15 months, 30 months
Time Frame	Baseline, 6 months, 9 months, 15 months, 30 months

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	GAD-Alum+Vitamin D+Etanercept
Arm/Group Description	All patients will from Day 1 receive 2 000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
Measure Participants	20
IL-4, baseline	0.01 (1.03)
IL-4, 6 months	0.01 (0.58)
IL-4, 9 months	0.01 (1.21)
IL-4, 15 months	0.01 (1.52)
IL-4, 30 months	0.01 (0.63)

29. Secondary Outcome

Title	GAD65-induced IL-13 Secretion
Description	GAD65-induced IL-13 secretion at baseline, 6 months, 9 months, 15 months, 30 months
Time Frame	Baseline, 6 months, 9 months, 15 months, 30 months

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	GAD-Alum+Vitamin D+Etanercept
Arm/Group Description	All patients will from Day 1 receive 2 000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
Measure Participants	20
IL-13, Baseline	0.01 (56.88)
IL-13, 6 months	1.67 (58.47)
IL-13, 9 months	5.12 (69.63)
IL-13, 15 months	0.01 (99.00)
IL-13, 30 months	0.01 (49.95)

30. Secondary Outcome

Title	GAD65-induced IFN-gamma Secretion
Description	GAD65-induced IFN-gamma secretion at baseline, 6 months, 9 months, 15 months, 30 months
Time Frame	Baseline, 6 months, 9 months, 15 months, 30 months

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	GAD-Alum+Vitamin D+Etanercept
Arm/Group Description	All patients will from Day 1 receive 2 000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
Measure Participants	20
IFN-gamma, baseline	4.39 (210.52)
IFN-gamma, 6 months	11.44 (223.16)
IFN-gamma, 9 months	22.77 (679.35)
IFN-gamma, 15 months	0.01 (1679.59)
IFN-gamma, 30 months	0.01 (227.91)

31. Secondary Outcome

Title	GAD65-induced TNF-alpha Secretion
Description	GAD65-induced TNF-alpha secretion at baseline, 6 months, 9 months, 15 months, 30 months
Time Frame	Baseline, 6 months, 9 months, 15 months, 30 months

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	GAD-Alum+Vitamin D+Etanercept
Arm/Group Description	All patients will from Day 1 receive 2 000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
Measure Participants	20
TNF-alpha, baseline	0.01 (348.28)
TNF-alpha, 6 months	0.01 (89.19)
TNF-alpha, 9 months	0.01 (355.09)
TNF-alpha, 15 months	0.01 (362.35)
TNF-alpha, 30 months	0.01 (206.37)

32. Secondary Outcome

Title	GAD65-induced GM-CSF Secretion
Description	GAD65-induced GM-CSF secretion baseline, 6 months, 9 months, 15 months, 30 months
Time Frame	Baseline, 6 months, 9 months, 15 months, 30 months

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	GAD-Alum+Vitamin D+Etanercept
Arm/Group Description	All patients will from Day 1 receive 2 000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
Measure Participants	20
GM-CSF, baseline	0.01 (16.96)
GM-CSF, 6 months	0.01 (18.00)
GM-CSF, 9 months	1.52 (24.70)
GM-CSF, 15 months	0.01 (36.95)
GM-CSF, 30 months	0.01 (6.00)

33. Secondary Outcome

Title	GAD65-induced MIP-1b Secretion
Description	GAD65-induced MIP-1b secretion at baseline, 6 months, 9 months, 15 months, 30 months
Time Frame	Baseline, 6 months, 9 months, 15 months, 30 months

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	GAD-Alum+Vitamin D+Etanercept
Arm/Group Description	All patients will from Day 1 receive 2 000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
Measure Participants	20
MIP-1b, baseline	0.01 (85.46)
MIP-1b, 6 months	0.01 (57.78)
MIP-1b, 9 months	0.01 (134.30)
MIP-1b, 15 months	30.64 (302.04)
MIP-1b, 30 months	14.61 (72.54)

34. Secondary Outcome

Title	GAD65-induced MCP-1 Secretion
Description	GAD65-induced MCP-1 secretion at baseline, 6 months, 9 months, 15 months, 30 months
Time Frame	Baseline, 6 months, 9 months, 15 months, 30 months

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	GAD-Alum+Vitamin D+Etanercept
Arm/Group Description	All patients will from Day 1 receive 2 000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
Measure Participants	20
MCP-1, baseline	0.01 (106.61)
MCP-1, 6 months	38.54 (89.74)
MCP-1, 9 months	0.01 (144.03)
MCP-1, 15 months	24.42 (203.74)
MCP-1, 30 months	37.50 (220.66)

Adverse Events

Time Frame	30 months
Adverse Event Reporting Description	Adverse Events were recorded in the Case Report Form at each clinic visit.
Arm/Group Title	GAD-Alum+Vitamin D+Etanercept
Arm/Group Description	All patients will from Day 1 receive 2 000 IU vitamin D per os per day during 15 months, and from Days 1-90 receive etanercept (Enbrel) injected subcutaneously 0.8 mg/kg body weight (max 50 mg) once a week, and receive 2 subcutaneous injections of 20 μg Diamyd in a prime-and-boost regimen on Days 30 and 60. GAD-Alum Vitamin D Etanercept
All Cause Mortality
	GAD-Alum+Vitamin D+Etanercept
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Serious Adverse Events
	GAD-Alum+Vitamin D+Etanercept
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	GAD-Alum+Vitamin D+Etanercept
	Affected / at Risk (%)	# Events
Total	20/20 (100%)
Gastrointestinal disorders
Diarrhoea	2/20 (10%)	2
General disorders
Injection site reaction	13/20 (65%)	20
Pyrexia	2/20 (10%)	2
Infections and infestations
Gastroenteritis	9/20 (45%)	11
Influenza	2/20 (10%)	2
Nasopharyngitis	13/20 (65%)	30
Viral infection	8/20 (40%)	15
Injury, poisoning and procedural complications
Ligament sprain	2/20 (10%)	2
Psychiatric disorders
Depression	2/20 (10%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.