CAPITOL: Study to Assess Patient Management Practices and Quality of Life With Paricalcitol Capsules in the Treatment of Secondary Hyperparathyroidism in Stage 3-5 Chronic Kidney Disease Patients Not Yet on Dialysis

• Sponsor: AbbVie (prior sponsor, Abbott) (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01265992
• Collaborator: Pharma Consulting Group AB (Industry)
• Enrollment: 50
• Locations: 10
• Duration (Months): 21
• Patients Per Site: 5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

Paricalcitol capsules (Zemplar®) received marketing authorization in Sweden in late 2007 for the prevention and treatment of secondary hyperparathyroidism in patients with Stage 3 & 4 Chronic Kidney Disease (CKD). Accordingly, additional data is needed to evaluate the effectiveness and safety of paricalcitol therapy under conditions of usual clinical care in Sweden.

This observational study is designed to collect data to evaluate safety and effectiveness during 6 months of therapy with paricalcitol capsules prescribed for patients with CKD Stages 3-5 not yet on dialysis. Data will also be collected on patient quality of life and costs associated with patient care.

Condition or Disease	Intervention/Treatment	Phase
Secondary Hyperparathyroidism; Chronic Kidney Disease

Detailed Description

This observational study is designed to collect data to evaluate safety and effectiveness during 6 months of therapy with paricalcitol capsules prescribed in accordance with the terms of the marketing authorization for patients with Chronic Kidney Disease (CKD) Stages 3-5 not yet on dialysis. Data will also be collected on patient quality of life and costs associated with patient care. A retrospective chart review of patient laboratory and medication history will provide historical data to determine drivers for initiation of paricalcitol therapy.

The primary goal of this post-marketing observational study (PMOS) is to further characterize the prescribing habits and patient management practices of physicians prescribing paricalcitol capsules and to assess the metabolic safety and effectiveness of paricalcitol capsules for the treatment of secondary hyperparathyroidism in Stage 3-5 CKD patients not yet on dialysis under conditions of usual clinical care. Focus will be to examine the practice of dose titration in early stages of CKD, understand real-world management of intact parathyroid hormone levels, understand real-world incidence and management of abnormalities in serum calcium and phosphate, and to examine patient bone and mineral profiles and medical history to understand drivers for paricalcitol capsules use.

Patients prescribed paricalcitol therapy for the first time will be asked to participate in the study. Enrolled patients will be followed for 6 months.

Study Design

• Study Type: Observational
• Actual Enrollment: 50 participants
• Time Perspective: Prospective
• Official Title: Post Marketing Observational Study to Assess Patient Management Practices and Quality of Life With the Capsules Form of Paricalcitol in the Treatment of SHPT in Stage 3 - 5 Chronic Kidney Disease Patients Not Yet on Dialysis Under Conditions of Usual Clinical Care (CAPITOL)
• Study Start Date: Feb 1, 2011
• Actual Primary Completion Date: Nov 1, 2012
• Actual Study Completion Date: Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Paricalcitol capsules Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Intact Parathyroid Hormone at 6 Months [Baseline and 6 months]

2. Percentage of Participants With Intact Parathyroid Hormone Within K/DOQI Target Range at Baseline and 6 Months [Baseline and 6 months]

   Kidney Disease Outcomes Quality Initiative (K/DOQI) target intact parathyroid hormone (iPTH) levels are: Stage 3 CKD (estimated Glomerular Filtration Rate* [eGFR] 30 - 59 mL/min): 3.85 - 7.7 pmol/L; Stage 4 CKD (eGFR 15 - 29 mL/min): 7.7 - 12.1 pmol/L; Stage 5 CKD (eGFR < 15 mL/min): 16.5 - 33 pmol/L. *Calculated using the Modification of Diet in Renal Disease formula.

3. Percentage of Participants With Elevated Serum-Phosphorus (s-P) Levels at Baseline and 6 Months [Baseline and 6 months]

   Elevated serum phosphorus is defined according to the 2003 Kidney Disease Outcomes Quality Initiative (K/DOQI) target definitions as: Stage 3 CKD: ≥ 1.49 mmol/L; Stage 4 CKD: ≥ 1.49 mmol/L; Stage 5 CKD: > 1.78 mmol/L.

4. Percentage of Participants With Elevated Serum-Calcium (s-Ca) Levels at Baseline and 6 Months [Baseline and 6 months]

   Elevated serum calcium is defined according to the 2003 Kidney Disease Outcomes Quality Initiative (K/DOQI) target definitions of s-Ca above 2.37 mmol/L.

Secondary Outcome Measures

1. Change From Baseline in Proteinuria [Baseline and Month 6]

   Proteinuria is the presence of excess serum proteins, or albumin, in the urine. Proteinuria was measured by the amount of albumin per liter of urine.

2. Percentage of Participants With a Reduction of Proteinuria of at Least 15% From Baseline [Baseline and 6 months]

3. Change From Baseline in Quality of Life Assessed by the Kidney Disease Quality of Life-Short Form (KDQOL-SF) [Baseline and 6 months]

   The KDQOL-SF is a self-report measure developed for individuals with kidney disease. It includes 43 end-stage renal disease (ESRD)-targeted items focused on particular areas of concern for individuals with kidney disease (Symptoms/problems, Effects of the disease on daily life, Burden of disease, Work status, Cognitive function, Quality of social interaction, Sexual function, Sleep, and Social support), 36 items (SF-36) that provide 8 measures of physical and mental health (Physical functioning, Role limitations caused by physical health limitations, Role limitations caused by emotional health problems, Social functioning, Emotional well-being, Pain, Energy/fatigue and General health perceptions), and 1 overall health rating item where respondents rate their health on a scale from 0 ("worst possible health") to 10 ("best possible health"). Scores are transformed and calculated such that each scale score ranges from 0 to 100 where higher scores reflect a better quality of life.

4. Total Direct Costs of Care Associated With Secondary Hyperparathyroidism [6 months]

   Direct medical costs to be calculated included outpatient visits, hospitalizations, pharmaceuticals, etc. However the data collected in this observational study was not enough to support this calculation.

5. Total Indirect Costs of Care Associated With Secondary Hyperparathyroidism [6 months]

   Indirect costs were estimated by using the number of hours missed from work (absenteeism) multiplied by the average hourly labor cost, including wages and benefits, to calculate average lost productivity costs due to absenteeism during the preceding 7 days. Hours missed from work were assessed using the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI-GH) questionnaire, in which respondents answer 6 questions related to work productivity and impairment. Unit costs were taken from official sources (Statistics Sweden, www.scb.se) and published literature.

6. Number of Participants Using Concomitant Medications at Baseline [Baseline]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Patients must sign the Informed Consent Form prior to inclusion into the study

• Patients should satisfy the Swedish Summary of Product Characteristics (SPC) for paricalcitol capsules at www.fass.se

• Patients must be 18 years or older with a diagnosis of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 - 5 (estimated Glomerular Filtration Rate between 10-59 by Modification of Diet in Renal Disease) but not yet on dialysis

• Patients should be in stable condition and have a life expectancy of at least 6 months

• Patients should not be expected to be transplanted or initiate dialysis for at least 6 months

Exclusion Criteria:

• Patients with CKD receiving dialysis

• Patients contraindicated for paricalcitol capsules as described in the SPC

• Treatment with paricalcitol more than 20 days prior to study enrollment

• History of drug or alcohol abuse within 6 months prior to inclusion

• History of non-compliance with medication or a medical history (i.e. psychiatric) that could enhance non-compliance with medication as determined by the investigator

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site Reference ID/Investigator# 47723	Kalmar		Sweden	391 85
2	Site Reference ID/Investigator# 41084	Karlstad		Sweden	651 85
3	Site Reference ID/Investigator# 45190	Kristianstad		Sweden	291 85
4	Site Reference ID/Investigator# 41085	Linkoping		Sweden	581 85
5	Site Reference ID/Investigator# 41087	Norrkoping		Sweden	601 82
6	Site Reference ID/Investigator# 45188	Orebro		Sweden	701 85
7	Site Reference ID/Investigator# 41088	Skovde		Sweden	541 85
8	Site Reference ID/Investigator# 57782	Stockholm		Sweden	112 81
9	Site Reference ID/Investigator# 41089	Varnamo		Sweden	331 85
10	Site Reference ID/Investigator# 45191	Vasteras		Sweden	721 89

Sponsors and Collaborators

• AbbVie (prior sponsor, Abbott)
• Pharma Consulting Group AB

Investigators

• Study Director: Eva Dahl, MD, AbbVie

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: AbbVie (prior sponsor, Abbott)
• ClinicalTrials.gov Identifier: NCT01265992
• Other Study ID Numbers: P12-270
• First Posted: Dec 24, 2010
• Last Update Posted: Feb 19, 2014
• Last Verified: Jan 1, 2014

• Keywords provided by AbbVie (prior sponsor, Abbott): Secondary hyperparathyroidism; Mineral and Bone Disorder (CKD-MBD); Chronic Kidney Disease
• Additional relevant MeSH terms: Neoplasm Metastasis; Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary

Study Results

Participant Flow

Arm/Group Title	Paricalcitol Capsules
Arm/Group Description	Patients with secondary hyperparathyroidism associated with Stage 3 - 5 chronic kidney disease (CKD) and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
Period Title: Overall Study
STARTED	50
Received Treatment	49
COMPLETED	41
NOT COMPLETED	9

Baseline Characteristics

Arm/Group Title	Paricalcitol Capsules
Arm/Group Description	Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
Overall Participants	49
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.7 (11.5)
Sex: Female, Male (Count of Participants)
Female	11 22.4%
Male	38 77.6%
Race/Ethnicity, Customized (participants) [Number]
White	49 100%
Black	0 0%
Asian	0 0%
American (Indian/Alaska Native)	0 0%
Other	0 0%
Region of Enrollment (participants) [Number]
Sweden	49 100%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Intact Parathyroid Hormone at 6 Months
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

Per-Protocol Analysis Set (PPAS), defined as all included participants who received at least 1 dose of paricalcitol capsules and had analyzable data for the primary endpoints, i.e., 5 - 8 months after inclusion, and with available iPTH data at both time points.

Arm/Group Title	Paricalcitol Capsules
Arm/Group Description	Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
Measure Participants	36
Mean (Standard Deviation) [pmol/L]	-6.2 (13.0)

2. Primary Outcome

Title	Percentage of Participants With Intact Parathyroid Hormone Within K/DOQI Target Range at Baseline and 6 Months
Description	Kidney Disease Outcomes Quality Initiative (K/DOQI) target intact parathyroid hormone (iPTH) levels are: Stage 3 CKD (estimated Glomerular Filtration Rate* [eGFR] 30 - 59 mL/min): 3.85 - 7.7 pmol/L; Stage 4 CKD (eGFR 15 - 29 mL/min): 7.7 - 12.1 pmol/L; Stage 5 CKD (eGFR < 15 mL/min): 16.5 - 33 pmol/L. *Calculated using the Modification of Diet in Renal Disease formula.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

Per-protocol analysis set. Three participants had missing data at Baseline and one participant had missing data at the 6 month visit; percentages are based on the total number of participants in the per-protocol analysis set (40).

Arm/Group Title	Paricalcitol Capsules
Arm/Group Description	Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
Measure Participants	40
Baseline	15.0 30.6%
6 months	27.5 56.1%

3. Primary Outcome

Title	Percentage of Participants With Elevated Serum-Phosphorus (s-P) Levels at Baseline and 6 Months
Description	Elevated serum phosphorus is defined according to the 2003 Kidney Disease Outcomes Quality Initiative (K/DOQI) target definitions as: Stage 3 CKD: ≥ 1.49 mmol/L; Stage 4 CKD: ≥ 1.49 mmol/L; Stage 5 CKD: > 1.78 mmol/L.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

Per-protocol analysis set. Two patients had missing s-P data at month 6; percentages are based on the total number of participants in the per-protocol analysis set (40).

Arm/Group Title	Paricalcitol Capsules
Arm/Group Description	Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
Measure Participants	40
Baseline	15.0 30.6%
6 months	25.0 51%

4. Primary Outcome

Title	Percentage of Participants With Elevated Serum-Calcium (s-Ca) Levels at Baseline and 6 Months
Description	Elevated serum calcium is defined according to the 2003 Kidney Disease Outcomes Quality Initiative (K/DOQI) target definitions of s-Ca above 2.37 mmol/L.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

Per-protocol analysis set. One participant had missing s-Ca data at Baseline and one participant had missing s-Ca data at month 6; percentages are based on the total number of participants in the per-protocol analysis set (40).

Arm/Group Title	Paricalcitol Capsules
Arm/Group Description	Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
Measure Participants	40
Baseline	42.5 86.7%
6 months	42.5 86.7%

5. Secondary Outcome

Title	Change From Baseline in Proteinuria
Description	Proteinuria is the presence of excess serum proteins, or albumin, in the urine. Proteinuria was measured by the amount of albumin per liter of urine.
Time Frame	Baseline and Month 6

Outcome Measure Data

Analysis Population Description

Per-protocol analysis set with available data at both time points.

Arm/Group Title	Paricalcitol Capsules
Arm/Group Description	Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
Measure Participants	10
Mean (Standard Deviation) [g/L]	0.2 (0.7)

6. Secondary Outcome

Title	Percentage of Participants With a Reduction of Proteinuria of at Least 15% From Baseline
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

Per-protocol analysis set. Percentages are based on the total number of participants in the per-protocol analysis set.

Arm/Group Title	Paricalcitol Capsules
Arm/Group Description	Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
Measure Participants	40
Number [percentage of participants]	10.0 20.4%

7. Secondary Outcome

Title	Change From Baseline in Quality of Life Assessed by the Kidney Disease Quality of Life-Short Form (KDQOL-SF)
Description	The KDQOL-SF is a self-report measure developed for individuals with kidney disease. It includes 43 end-stage renal disease (ESRD)-targeted items focused on particular areas of concern for individuals with kidney disease (Symptoms/problems, Effects of the disease on daily life, Burden of disease, Work status, Cognitive function, Quality of social interaction, Sexual function, Sleep, and Social support), 36 items (SF-36) that provide 8 measures of physical and mental health (Physical functioning, Role limitations caused by physical health limitations, Role limitations caused by emotional health problems, Social functioning, Emotional well-being, Pain, Energy/fatigue and General health perceptions), and 1 overall health rating item where respondents rate their health on a scale from 0 ("worst possible health") to 10 ("best possible health"). Scores are transformed and calculated such that each scale score ranges from 0 to 100 where higher scores reflect a better quality of life.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

Per-protocol analysis set with available data at both time points.

Arm/Group Title	Paricalcitol Capsules
Arm/Group Description	Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
Measure Participants	24
ESRD: Symptom/problem scale	-0.4 (12.9)
ESRD: Effects of kidney disease	-0.2 (9.4)
ESRD: Burden of kidney disease	-1.0 (19.5)
ESRD: Work status	-10.4 (29.4)
ESRD: Cognitive function	-2.5 (19.7)
ESRD: Quality of social interaction	1.7 (20.3)
ESRD: Sexual function	-0.6 (23.0)
ESRD: Sleep	0.9 (11.3)
ESRD: Social Support	-4.9 (17.4)
SF-36: Physical functioning	5.7 (18.6)
SF-36: Role physical	-7.3 (36.5)
SF-36: Pain	-2.3 (22.1)
SF-36: General health	1.5 (16.6)
SF-36: Emotional well-being	-3.0 (13.4)
SF-36: Role emotional	-11.1 (36.3)
SF-36: Social function	0.5 (22.0)
SF-36: Energy/fatigue	1.9 (22.4)
Overall health rating	1.3 (15.4)

8. Secondary Outcome

Title	Total Direct Costs of Care Associated With Secondary Hyperparathyroidism
Description	Direct medical costs to be calculated included outpatient visits, hospitalizations, pharmaceuticals, etc. However the data collected in this observational study was not enough to support this calculation.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Paricalcitol Capsules
Arm/Group Description	Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
Measure Participants	0

9. Secondary Outcome

Title	Total Indirect Costs of Care Associated With Secondary Hyperparathyroidism
Description	Indirect costs were estimated by using the number of hours missed from work (absenteeism) multiplied by the average hourly labor cost, including wages and benefits, to calculate average lost productivity costs due to absenteeism during the preceding 7 days. Hours missed from work were assessed using the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI-GH) questionnaire, in which respondents answer 6 questions related to work productivity and impairment. Unit costs were taken from official sources (Statistics Sweden, www.scb.se) and published literature.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Participants who were working for pay and with available data at both time points.

Arm/Group Title	Paricalcitol Capsules
Arm/Group Description	Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
Measure Participants	11
Absenteeism: Baseline	0 (0)
Absenteeism: 6 months	1,318 (2,642)

10. Secondary Outcome

Title	Number of Participants Using Concomitant Medications at Baseline
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Full analysis set

Arm/Group Title	Paricalcitol Capsules
Arm/Group Description	Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
Measure Participants	49
Agents acting on the renin-angiotensin system	39 79.6%
All other therapeutic products	11 22.4%
Angiotensin II antagonists, plain	1 2%
Antianemic preparations	10 20.4%
Antigout preparations	9 18.4%
Antihypertensives	5 10.2%
Antiprotozoals	1 2%
Antithrombotic agents	2 4.1%
Beta blocking agents	22 44.9%
Blood substitutes and perfusion solutions	10 20.4%
Calcium channel blockers	27 55.1%
Calcium homeostasis	1 2%
Cardiac therapy	1 2%
Diuretics	28 57.1%
Drugs for obstructive airway diseases	1 2%
Drugs used in diabetes	3 6.1%
Immunosuppressive agents	1 2%
Lipid modifying agents	28 57.1%
Mineral supplements	10 20.4%
Vitamins	2 4.1%

Adverse Events

Time Frame	6 months
Adverse Event Reporting Description	Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Arm/Group Title	Paricalcitol Capsules
Arm/Group Description	Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
All Cause Mortality
	Paricalcitol Capsules
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Paricalcitol Capsules
	Affected / at Risk (%)	# Events
Total	12/49 (24.5%)
Cardiac disorders
Acute myocardial infarction	1/49 (2%)
Cardiovascular disorder	1/49 (2%)
Cardiac failure congestive	1/49 (2%)
Left ventricular failure	1/49 (2%)
Gastrointestinal disorders
Nausea	1/49 (2%)
General disorders
Asthenia	1/49 (2%)
Chest pain	2/49 (4.1%)
General physical health deterioration	2/49 (4.1%)
Pyrexia	1/49 (2%)
Infections and infestations
Appendicitis	1/49 (2%)
Diverticulitis	1/49 (2%)
Pneumonia	1/49 (2%)
Urinary tract infection	1/49 (2%)
Investigations
Weight decreased	1/49 (2%)
Metabolism and nutrition disorders
Decreased appetite	1/49 (2%)
Dehydration	1/49 (2%)
Hyperglycaemia	1/49 (2%)
Musculoskeletal and connective tissue disorders
Back pain	2/49 (4.1%)
Muscular weakness	2/49 (4.1%)
Nervous system disorders
Ageusia	1/49 (2%)
Ataxia	1/49 (2%)
Cerebral infarction	1/49 (2%)
Cerebrovascular disorder	1/49 (2%)
Cognitive disorder	1/49 (2%)
Coordination abnormal	1/49 (2%)
Dizziness	2/49 (4.1%)
Dysarthria	2/49 (4.1%)
Hemiparesis	1/49 (2%)
Memory impairment	1/49 (2%)
VIIth nerve paralysis	1/49 (2%)
Renal and urinary disorders
Anuria	1/49 (2%)
Azotaemia	1/49 (2%)
Glomerulonephritis rapidly progressive	1/49 (2%)
Haematuria	1/49 (2%)
Renal failure chronic	2/49 (4.1%)
Respiratory, thoracic and mediastinal disorders
Cough	1/49 (2%)
Dyspnoea	2/49 (4.1%)
Vascular disorders
Aortic aneurysm rupture	1/49 (2%)
Arteriovenous fistula	1/49 (2%)
Hypotension	2/49 (4.1%)
Poor peripheral circulation	1/49 (2%)
Other (Not Including Serious) Adverse Events
	Paricalcitol Capsules
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.