Synergy: A Phase II Trial Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis

• Sponsor: Zalicus (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01369745
• Collaborator: (none)
• Enrollment: 294
• Location: 1
• Arms: 5
• Duration (Months): 15
• Patients Per Site Per Month: 19.5

Study Details

Study Description

Brief Summary

Thus study will test an experimental drug called Z-102 (combination of prednisolone and dipyridamole) to treat patients with moderate to severe rheumatoid arthritis.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: Prednisolone; Drug: dipyridamole; Drug: Prednisone; Drug: Z102; Other: placebo	Phase 2

Detailed Description

The primary objective of the study was to demonstrate the efficacy of Z102 (2.7 mg prednisolone/360 mg dipyridamole) versus placebo on the Disease Activity Score 28 using C reactive protein (DAS28-CRP) in subjects with rheumatoid arthritis at the study endpoint of 12 weeks

Study Design

• Study Type: Interventional
• Actual Enrollment: 294 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase II, Double-Blind, Placebo-Controlled, Multi-Center, Randomized Withdrawal Design Trial Using Adaptive Randomization Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis
• Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Prednisolone Prednisolone 2.7 mg daily for 12 weeks	Drug: Prednisolone; Prednisolone 2.7 mg daily
Active Comparator: dipyridamole Dipyridamole 360 mg daily for 12 weeks	Drug: dipyridamole; dipyridamole 360 mg daily
Active Comparator: prednisone Prednisone 5 mg daily for 12 weeks	Drug: Prednisone; Prednisone 5 mg daily
Experimental: Z102 (2.7/360) Prednisolone 2.7 mg plus dipyridamole 360 mg daily for 12 weeks	Drug: Z102; Prednisolone 2.7 mg plus dipyridamole 360 mg daily; Other Names: prednisolone dipyridamole
Placebo Comparator: placebo Placebo daily for 12 weeks	Other: placebo

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in DAS28-CRP at 12 Weeks [baseline to week 12]

   The primary efficacy endpoint was the mean change in Disease Activity Score 28 using C-reactive protein (DAS28-CRP) from baseline to Week 12. The DAS28-CRP is a composite measure of inflammation in Rheumatoid Arthritis and incorporates a tender and swollen joint count, CRP and Patient Global Assessment of Disease Activity expressed in a Gaussian distribution of variables ranging from 0 to 10. A DAS28-CRP score of <3.2 suggests a low level of disease activity, while a score of >5.1 suggests a high level of disease activity. Using the DAS-CRP as a continuous scale allows investigators (and clinicians) to measure a clinically meaningful endpoint following institution of a therapeutic intervention. In RA, clinical remission would therefore be graded as a DAS28 score of ≤3.2 with disease flare accompanying scores of ≥5.1; well-controlled disease is best characterized as fitting in between these two scores.

Secondary Outcome Measures

1. Change From Baseline in DAS28-CRP Individual Components at 12 Weeks [Baseline to week 12]

   The mean change in the individual components of the Disease Activity Score 28 using C-reactive protein (DAS28-CRP) from baseline to Week 12 which included individual assessment of Tender Joint Count (28-joint assessment), Swollen Joint Count (28-joint assessment), Patient Global Assessment of Disease Activity and absolute CRP level. In each case, higher scores indicate more disease activity. The DAS28-CRP is a composite measure of inflammation in Rheumatoid Arthritis and incorporates a tender and swollen joint count, CRP and Patient Global Assessment of Disease Activity expressed in a Gaussian distribution of variables ranging from 0 to 10. A DAS28-CRP score of <3.2 suggests a low level of disease activity, while a score of >5.1 suggests a high level of disease activity.

2. Percentage of Subjects Achieving ACR20, ACR50 and ACR70 at 12 Weeks [Week 12]

   The American College of Rheumatology (ACR) 20 is a widely accepted composite index of improvement in RA proposed by the ACR (Fransen and van Riel 2009). ACR20 refers to a composite improvement of 20% in swollen joint count, tender joint count, and 3 or more of the following 5 measures:Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, Patient Pain VAS, Patient's self-addressed disability (HAQ) (Arnet 1988 and Felson 1995), Acute-phase reactant (ESR or CRP) The ACR 50 and ACR 70 are similar tools, used to indicate 50% and 70% improvement, respectively.

3. Multidimensional Assessment of Fatigue (MAF) at Week 12 [week 12]

   The Multidimensional Assessment of Fatigue (MAF) scale contains 16 items and measures four dimensions of fatigue: severity (#1-2), distress (#3), degree of interference in activities of daily living (#4-14), and timing (#15-16). Fourteen items contain numerical rating scales (#1-14) and two items have multiple-choice responses (#15-16). Respondents are asked to reflect on fatigue patterns for the past week. To calculate the Global Fatigue Index (GFI): Convert item #15 to a 0-10 scale by multiplying each score by 2.5 and then sum items #1, 2, 3, average #4-14, and newly scored item #15. Scores range from 1 (no fatigue) to 50 (severe fatigue). Do not assign a score to items #4-14 if respondent indicated they "do not do any activity for reasons other than fatigue." If respondents select no fatigue on item #1, assign a zero to items #2-16. Item #16 is not included in the Global Fatigue Index.

4. Time to Failure (Days) [Baseline to 12 weeks]

   Patients will be monitored for addition of any DMARD or withdrawal due to flare. The time to failure is defined as the duration of study participation (in days) until a qualifying event or completion of study treatment, whichever comes first.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Meet the ACR / EULAR criteria for classification of RA

• Have moderate to severe RA, defined as involving a minimum (≥6 total swollen and ≥6 total tender) of the 28 joints assessed

• Have screening CRP levels of at least 0.6 mg/dl and a DAS28-CRP score ≥4.5

• Have been on a stable dose of conventional DMARD therapy for at least 90 days without dosage adjustment or modification and should be able to maintain the same dose of conventional DMARD therapy during study participation (with or without glucocorticoid therapy

Exclusion Criteria:

• Treatment-refractory patients are excluded

• Has active cardiovascular disease, unless well controlled by appropriate treatment for a minimum of 3 months prior to screening

• Is taking aspirin for reasons other than for cardiovascular prophylaxis or their total daily dose is greater than 325 mg

• Is currently taking steroids at a daily prednisone dose, or the equivalent, of >10 mg

• Intraarticular, intramuscular, or intravenous glucocorticoids must not have been given at least 6 weeks prior to entering the study

• The need to continue the use of one or multiple NSAID's at the same time, or the use of acetaminophen on a chronic basis

• All opiate use is prohibited

• Use of any other medications or herbs used for the treatment of pain is prohibited

• Patients with a history of or currently active tuberculosis as per specific country guidelines are excluded

• Has uncontrolled diabetes mellitus as defined by a serum glucose >126 mg/dl

• Knowingly has HIV infection or hepatitis

• Has undergone administration of any investigational drug within 30 days of study initiation

• All biologic agents are excluded for 90 days prior to Screening and throughout the study.

• Has undergone administration of rituximab or any B-cell depleting investigational drugs within 6 months of study initiation

• Has had a history of alcohol or drug abuse within the past 2 years

• Has a history of hypersensitivity to glucocorticoids and/or dipyridamole

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zalicus Investigational Site	Toledo	Ohio	United States	43606

Sponsors and Collaborators

• Zalicus

Investigators

• Study Director: Margaret Lee, PhD, Zalicus, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zalicus
• ClinicalTrials.gov Identifier: NCT01369745
• Other Study ID Numbers: Z102-008
• First Posted: Jun 9, 2011
• Last Update Posted: May 15, 2014
• Last Verified: Apr 1, 2014

• Keywords provided by Zalicus: Rheumatoid Arthritis; Moderate to severe
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Prednisone; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Dipyridamole; Prednisolone hemisuccinate; Prednisolone phosphate

Study Results

Participant Flow

Pre-assignment Detail	A total of 294 subjects entered the titration phase. Of these, 258 subjects completed the titration phase, were randomized to treatment, received at least one dose of study drug and constitute the safety population. Of these, 252 subjects provided at least one post-baseline measurement of the primary endpoint and constitute the efficacy population.

Arm/Group Title	Prednisolone	Dipyridamole	Prednisone	Z102	Placebo
Arm/Group Description	Prednisolone 2.7 mg once daily	dipyridamole 360 mg once daily	Prednisone 5 mg once daily	2.7 mg prednisolone plus 360 mg dipyridamole once daily	placebo once daily
Period Title: Overall Study
STARTED	32	41	18	84	83
COMPLETED	25	28	16	64	65
NOT COMPLETED	7	13	2	20	18

Baseline Characteristics

Arm/Group Title	Prednisolone	Dipyridamole	Prednisone	Z102	Placebo	Total
Arm/Group Description	Prednisolone 2.7 mg once daily The trial would progress from Stage 1 to Stage 2 if the posterior probability that Z102 is superior to placebo was greater than 0.975.	dipyridamole 360 mg once daily The trial would progress from Stage 2 to Stage 3 if the posterior probability that Z102 is superior to dipyridamole was greater than 0.975.	Prednisone 5 mg once daily The trial would progress from Stage 2 to Stage 4 if the posterior probability that Z102 is superior to prednisolone 2.7 was greater than 0.975.	prednisolone 2.7 mg plus dipyridamole 360 mg once daily The trial would progress from Stage 3 to Stage 5 if the posterior probability that Z102 is superior to prednisolone 2.7 was greater than 0.975.	placebo once daily	Total of all reporting groups
Overall Participants	32	41	18	84	83	258
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.2 (12.69)	55.9 (9.35)	55.5 (9.82)	54.5 (11.53)	53.7 (12.44)	54.6 (11.5)
Sex: Female, Male (Count of Participants)
Female	26 81.3%	36 87.8%	17 94.4%	72 85.7%	75 90.4%	226 87.6%
Male	6 18.8%	5 12.2%	1 5.6%	12 14.3%	8 9.6%	32 12.4%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in DAS28-CRP at 12 Weeks
Description	The primary efficacy endpoint was the mean change in Disease Activity Score 28 using C-reactive protein (DAS28-CRP) from baseline to Week 12. The DAS28-CRP is a composite measure of inflammation in Rheumatoid Arthritis and incorporates a tender and swollen joint count, CRP and Patient Global Assessment of Disease Activity expressed in a Gaussian distribution of variables ranging from 0 to 10. A DAS28-CRP score of <3.2 suggests a low level of disease activity, while a score of >5.1 suggests a high level of disease activity. Using the DAS-CRP as a continuous scale allows investigators (and clinicians) to measure a clinically meaningful endpoint following institution of a therapeutic intervention. In RA, clinical remission would therefore be graded as a DAS28 score of ≤3.2 with disease flare accompanying scores of ≥5.1; well-controlled disease is best characterized as fitting in between these two scores.
Time Frame	baseline to week 12

Outcome Measure Data

Analysis Population Description

The efficacy analysis population includes all 252 subjects who received at least one dose of study drug after randomization and who provided at least one post-baseline measurement of the primary endpoint

Arm/Group Title	Prednisolone	Dipyridamole	Prednisone	Z102	Placebo
Arm/Group Description	Prednisolone 2.7 mg once daily	dipyridamole 360 mg once daily	Prednisone 5 mg once daily	prednisolone 2.7 mg plus dipyridamole 360 mg once daily	placebo once daily
Measure Participants	32	39	18	82	81
Mean (Standard Deviation) [units on a scale]	-1.147 (0.235)	-0.813 (0.216)	-1.237 (0.296)	-0.907 (0.149)	-0.538 (0.153)

2. Secondary Outcome

Title	Change From Baseline in DAS28-CRP Individual Components at 12 Weeks
Description	The mean change in the individual components of the Disease Activity Score 28 using C-reactive protein (DAS28-CRP) from baseline to Week 12 which included individual assessment of Tender Joint Count (28-joint assessment), Swollen Joint Count (28-joint assessment), Patient Global Assessment of Disease Activity and absolute CRP level. In each case, higher scores indicate more disease activity. The DAS28-CRP is a composite measure of inflammation in Rheumatoid Arthritis and incorporates a tender and swollen joint count, CRP and Patient Global Assessment of Disease Activity expressed in a Gaussian distribution of variables ranging from 0 to 10. A DAS28-CRP score of <3.2 suggests a low level of disease activity, while a score of >5.1 suggests a high level of disease activity.
Time Frame	Baseline to week 12

Outcome Measure Data

Analysis Population Description

Because the study never progressed past the first stage of the adaptive randomization, the number of subjects who were allocated to the dipyridamole 360 mg, prednisolone 2.7 mg, and prednisone 5 mg treatment arms was insufficient (underpowered) to allow analysis of the secondary objectives.

Arm/Group Title	Prednisolone	Dipyridamole	Prednisone	Z102	Placebo
Arm/Group Description	Prednisolone 2.7 mg once daily	dipyridamole 360 mg once daily	Prednisone 5 mg once daily	prednisolone 2.7 mg plus dipyridamole 360 mg once daily	placebo once daily
Measure Participants	0	0	0	0	0

3. Secondary Outcome

Title	Percentage of Subjects Achieving ACR20, ACR50 and ACR70 at 12 Weeks
Description	The American College of Rheumatology (ACR) 20 is a widely accepted composite index of improvement in RA proposed by the ACR (Fransen and van Riel 2009). ACR20 refers to a composite improvement of 20% in swollen joint count, tender joint count, and 3 or more of the following 5 measures:Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, Patient Pain VAS, Patient's self-addressed disability (HAQ) (Arnet 1988 and Felson 1995), Acute-phase reactant (ESR or CRP) The ACR 50 and ACR 70 are similar tools, used to indicate 50% and 70% improvement, respectively.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Because the study never progressed past the first stage of the adaptive randomization, the number of subjects who were allocated to the dipyridamole 360 mg, prednisolone 2.7 mg, and prednisone 5 mg treatment arms was insufficient (underpowered) to allow analysis of the secondary objectives.

Arm/Group Title	Prednisolone	Dipyridamole	Prednisone	Z102	Placebo
Arm/Group Description	Prednisolone 2.7 mg once daily	dipyridamole 360 mg once daily	Prednisone 5 mg once daily	prednisolone 2.7 mg plus dipyridamole 360 mg once daily	placebo once daily
Measure Participants	0	0	0	0	0

4. Secondary Outcome

Title	Multidimensional Assessment of Fatigue (MAF) at Week 12
Description	The Multidimensional Assessment of Fatigue (MAF) scale contains 16 items and measures four dimensions of fatigue: severity (#1-2), distress (#3), degree of interference in activities of daily living (#4-14), and timing (#15-16). Fourteen items contain numerical rating scales (#1-14) and two items have multiple-choice responses (#15-16). Respondents are asked to reflect on fatigue patterns for the past week. To calculate the Global Fatigue Index (GFI): Convert item #15 to a 0-10 scale by multiplying each score by 2.5 and then sum items #1, 2, 3, average #4-14, and newly scored item #15. Scores range from 1 (no fatigue) to 50 (severe fatigue). Do not assign a score to items #4-14 if respondent indicated they "do not do any activity for reasons other than fatigue." If respondents select no fatigue on item #1, assign a zero to items #2-16. Item #16 is not included in the Global Fatigue Index.
Time Frame	week 12

Outcome Measure Data

Analysis Population Description

Because the study never progressed past the first stage of the adaptive randomization, the number of subjects who were allocated to the dipyridamole 360 mg, prednisolone 2.7 mg, and prednisone 5 mg treatment arms was insufficient (underpowered) to allow analysis of the secondary objectives.

Arm/Group Title	Prednisolone	Dipyridamole	Prednisone	Z102	Placebo
Arm/Group Description	Prednisolone 2.7 mg once daily	dipyridamole 360 mg once daily	Prednisone 5 mg once daily	prednisolone 2.7 mg plus dipyridamole 360 mg once daily	placebo once daily
Measure Participants	0	0	0	0	0

5. Secondary Outcome

Title	Time to Failure (Days)
Description	Patients will be monitored for addition of any DMARD or withdrawal due to flare. The time to failure is defined as the duration of study participation (in days) until a qualifying event or completion of study treatment, whichever comes first.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

Because the study never progressed past the first stage of the adaptive randomization, the number of subjects who were allocated to the dipyridamole 360 mg, prednisolone 2.7 mg, and prednisone 5 mg treatment arms was insufficient (underpowered) to allow analysis of the secondary objectives.

Arm/Group Title	Prednisolone	Dipyridamole	Prednisone	Z102	Placebo
Arm/Group Description	Prednisolone 2.7 mg once daily	dipyridamole 360 mg once daily	Prednisone 5 mg once daily	prednisolone 2.7 mg plus dipyridamole 360 mg once daily	placebo once daily
Measure Participants	0	0	0	0	0

Adverse Events

Time Frame	Adverse event data were collected from the time of consent through the end of study visit at 12 weeks.
Adverse Event Reporting Description	Adverse events are reported for the safety population of 258 subjects randomized to the double blind study phase and who received at least one dose of study drug.
Arm/Group Title	Prednisolone		Dipyridamole		Prednisone		Z102		Placebo
Arm/Group Description	Prednisolone 2.7 mg daily		dipyridamole 360 mg once daily		Prednisone 5 mg once daily		prednisolone 2.7 mg plus dipyridamole 360 mg once daily		placebo once daily
All Cause Mortality
	Prednisolone		Dipyridamole		Prednisone		Z102		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Prednisolone		Dipyridamole		Prednisone		Z102		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/32 (3.1%)		2/41 (4.9%)		0/18 (0%)		5/84 (6%)		4/83 (4.8%)
Blood and lymphatic system disorders
Thrombocytopenia	0/32 (0%)	0	0/41 (0%)	0	0/18 (0%)	0	1/84 (1.2%)	1	0/83 (0%)	0
Haemolytic Anaemia	0/32 (0%)	0	0/41 (0%)	0	0/18 (0%)	0	0/84 (0%)	0	1/83 (1.2%)	1
Cardiac disorders
Angina Pectoris	0/32 (0%)	0	1/41 (2.4%)	1	0/18 (0%)	0	0/84 (0%)	0	0/83 (0%)	0
General disorders
Oedema Peripheral	1/32 (3.1%)	1	0/41 (0%)	0	0/18 (0%)	0	0/84 (0%)	0	0/83 (0%)	0
Injury, poisoning and procedural complications
Hip Fracture	0/32 (0%)	0	0/41 (0%)	0	0/18 (0%)	0	1/84 (1.2%)	1	0/83 (0%)	0
Humerus Fracture	0/32 (0%)	0	0/41 (0%)	0	0/18 (0%)	0	1/84 (1.2%)	1	0/83 (0%)	0
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis	0/32 (0%)	0	0/41 (0%)	0	0/18 (0%)	0	1/84 (1.2%)	1	0/83 (0%)	0
Nervous system disorders
Sciatica	0/32 (0%)	0	0/41 (0%)	0	0/18 (0%)	0	2/84 (2.4%)	2	1/83 (1.2%)	1
Renal and urinary disorders
Ureteric Obstruction	0/32 (0%)	0	0/41 (0%)	0	0/18 (0%)	0	0/84 (0%)	0	1/83 (1.2%)	1
Calculus Ureteric	0/32 (0%)	0	1/41 (2.4%)	1	0/18 (0%)	0	0/84 (0%)	0	0/83 (0%)	0
Vascular disorders
Deep Vein Thrombosis	0/32 (0%)	0	0/41 (0%)	0	0/18 (0%)	0	0/84 (0%)	0	1/83 (1.2%)	1
Other (Not Including Serious) Adverse Events
	Prednisolone		Dipyridamole		Prednisone		Z102		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/32 (18.8%)		30/41 (73.2%)		5/18 (27.8%)		38/84 (45.2%)		33/83 (39.8%)
Ear and labyrinth disorders
Vertigo	0/32 (0%)		2/41 (4.9%)		0/18 (0%)		1/84 (1.2%)		0/83 (0%)
Gastrointestinal disorders
Nausea	0/32 (0%)		2/41 (4.9%)		1/18 (5.6%)		3/84 (3.6%)		1/83 (1.2%)
Diarrhoea	0/32 (0%)		1/41 (2.4%)		1/18 (5.6%)		2/84 (2.4%)		1/83 (1.2%)
Abdominal Upper Pain	1/32 (3.1%)		3/41 (7.3%)		0/18 (0%)		1/84 (1.2%)		1/83 (1.2%)
General disorders
Fatigue	0/32 (0%)		1/41 (2.4%)		0/18 (0%)		0/84 (0%)		2/83 (2.4%)
Oedema Peripheral	1/32 (3.1%)		0/41 (0%)		0/18 (0%)		0/84 (0%)		2/83 (2.4%)
Infections and infestations
Urinary Tract Infection	0/32 (0%)		0/41 (0%)		0/18 (0%)		2/84 (2.4%)		0/83 (0%)
Nasopharyngitis	1/32 (3.1%)		1/41 (2.4%)		1/18 (5.6%)		1/84 (1.2%)		4/83 (4.8%)
Rash Pustular	0/32 (0%)		0/41 (0%)		0/18 (0%)		0/84 (0%)		2/83 (2.4%)
Respiratory Tract Infection	0/32 (0%)		0/41 (0%)		0/18 (0%)		0/84 (0%)		2/83 (2.4%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/32 (3.1%)		3/41 (7.3%)		1/18 (5.6%)		5/84 (6%)		8/83 (9.6%)
Rheumatoid Arthritis	0/32 (0%)		3/41 (7.3%)		1/18 (5.6%)		5/84 (6%)		4/83 (4.8%)
Back Pain	1/32 (3.1%)		3/41 (7.3%)		0/18 (0%)		1/84 (1.2%)		1/83 (1.2%)
Nervous system disorders
Headache	1/32 (3.1%)		11/41 (26.8%)		0/18 (0%)		13/84 (15.5%)		4/83 (4.8%)
Sciatica	0/32 (0%)		0/41 (0%)		0/18 (0%)		2/84 (2.4%)		1/83 (1.2%)
Skin and subcutaneous tissue disorders
Rash	0/32 (0%)		0/41 (0%)		0/18 (0%)		2/84 (2.4%)		0/83 (0%)

Limitations/Caveats

The study did not progress past the first stage of adaptive randomization. The number of subjects allocated to the dipyridamole 360 mg, prednisolone 2.7 mg, and prednisone 5 mg arms was insufficient to allow analysis of the secondary objectives.

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.