Trial Outcomes & Findings for Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sjögren's Syndrome (NCT NCT02843659)
NCT ID: NCT02843659
Last Updated: 2018-10-04
Results Overview
The ESSDAI is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening
TERMINATED
PHASE2
45 participants
At baseline and week 12
2018-10-04
Participant Flow
45 subjects enrolled, 18 subjects were randomized/treated. 15 subjects didn't complete the treatment period. The study was terminated and the remaining 15 randomized subjects who had not yet completed the double-blind period entered the follow-up period. Of the 15 subjects who entered the follow-up period, 12 did not complete the follow-up period
Participant milestones
| Measure |
BMS-931699/Lulizumab Injection
(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)
|
BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)
For oral administration, 350 mg
|
Placebo
For BMS-986142 50 mg tablet (round) or 150 mg tablet
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
6
|
7
|
|
Overall Study
COMPLETED
|
1
|
0
|
2
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
5
|
Reasons for withdrawal
| Measure |
BMS-931699/Lulizumab Injection
(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)
|
BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)
For oral administration, 350 mg
|
Placebo
For BMS-986142 50 mg tablet (round) or 150 mg tablet
|
|---|---|---|---|
|
Overall Study
Subject Withdrew Consent
|
0
|
0
|
1
|
|
Overall Study
Administrative Reason by Sponsor
|
4
|
5
|
4
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
Baseline Characteristics
Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sjögren's Syndrome
Baseline characteristics by cohort
| Measure |
BMS-931699/Lulizumab Injection
n=5 Participants
(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)
|
BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)
n=6 Participants
For oral administration, 350 mg
|
Placebo
n=7 Participants
For BMS-986142 50 mg tablet (round) or 150 mg tablet
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
49.2 Years
STANDARD_DEVIATION 11.34 • n=5 Participants
|
51.2 Years
STANDARD_DEVIATION 8.77 • n=7 Participants
|
52.6 Years
STANDARD_DEVIATION 13.30 • n=5 Participants
|
51.2 Years
STANDARD_DEVIATION 11.41 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At baseline and week 12Population: The study was terminated and data is not reported for privacy reasons
The ESSDAI is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline, week 4 and week 8Population: The study was terminated and data is not reported for privacy reasons
The ESSDAI is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline, week 4, week 8, and week 12Population: The study was terminated and data is not reported for privacy reasons
ESSPRI, also known as EULAR Sjogren's Syndrome Patient Reported Index, measures subjective symptoms of dryness, pain and fatigue. It uses 0-10 numerical scales, one for each domain. The weight of the domains is identical, and the final score is the mean score of the 3 domains.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At week 12Population: The study was terminated and data is not reported for privacy reasons
The ESSDAI is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At week 12Population: The study was terminated and data is not reported for privacy reasons
The ESSDAI is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At week 12Population: The study was terminated and data is not reported for privacy reasons
ESSPRI, also known as EULAR Sjogren's Syndrome Patient Reported Index, measures subjective symptoms of dryness, pain and fatigue. It uses 0-10 numerical scales, one for each domain. The weight of the domains is identical, and the final score is the mean score of the 3 domains
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline, week 4, week 8, and week 12Population: The study was terminated and data is not reported for privacy reasons
ESSPRI, also known as EULAR Sjogren's Syndrome Patient Reported Index, measures subjective symptoms of dryness, pain and fatigue. It uses 0-10 numerical scales, one for each domain. The weight of the domains is identical, and the final score is the mean score of the 3 domains
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline, week 4, week 8, and week 12Population: The study was terminated and data is not reported for privacy reasons
ESSPRI, also known as EULAR Sjogren's Syndrome Patient Reported Index, measures subjective symptoms of dryness, pain and fatigue. It uses 0-10 numerical scales, one for each domain. The weight of the domains is identical, and the final score is the mean score of the 3 domains
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline, week 4, week 8, and week 12Population: The study was terminated and data is not reported for privacy reasons
ESSPRI, also known as EULAR Sjogren's Syndrome Patient Reported Index, measures subjective symptoms of dryness, pain and fatigue. It uses 0-10 numerical scales, one for each domain. The weight of the domains is identical, and the final score is the mean score of the 3 domains
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline, week 4, week 8, and week 12Population: The study was terminated and data is not reported for privacy reasons
Serum and saliva biomarkers (collected from samples obtained during unstimulated and stimulated salivary flow assessments) were measured to determine the potential PD effect of BMS-931699 and BMS-986142 on disease-related protein analytes. These assessments included, but were not limited to, the detection of cytokines and other protein analytes by immunoassays and/or mass spectrometry proteomic profiling.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline, week 4, week 8, and week 12Population: The study was terminated and data is not reported for privacy reasons
Serum and saliva biomarkers (collected from samples obtained during unstimulated and stimulated salivary flow assessments) were measured to determine the potential PD effect of BMS-931699 and BMS-986142 on disease-related protein analytes. These assessments included, but were not limited to, the detection of cytokines and other protein analytes by immunoassays and/or mass spectrometry proteomic profiling.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline, week 4, week 8, and week 12Population: The study was terminated and data is not reported for privacy reasons
The test was performed by instillation of fluorescein dye and either lissamine green or Rose bengal dye to stain the cornea and conjunctiva, respectively. After instilling the dye, the ocular surface was examined through a slit lamp (biomicroscope).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline, week 4, week 8, and week 12Population: The study was terminated and data is not reported for privacy reasons
The test (without anaesthesia) was performed by placing a narrow calibrated filter-paper strip in the inferior cul-de-sac of each eye. Aqueous tear production was measured by the length in millimeters that the strip wets during the 5 minute test period
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline, week 4, week 8, and week 12Population: The study was terminated and data is not reported for privacy reasons
Determined by instilling fluorescein dye and evaluating the stability of the pre-corneal tear film. After several blinks, the tear film is examined using a broad beam of the slit-lamp (biomicroscope) with a cobalt blue filter. The TBUT, defined as the time in seconds between the subjects's last blink and the first appearance of a random dry spot on the corneal surface, is measured 3 times and the mean value is recorded.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline, at week 2, week 4, week 6, week 8, week 10, week 12, and week 18Population: The study was terminated and data is not reported for privacy reasons
The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. 0 = No Pain, 1-3 = Mild Pain(nagging, annoying, interfering little with ADLs), 4-6 = Moderate Pain (interferes significantly with ADLs), 7-10 = Severe Pain (disabling; unable to perform ADLs)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline, week 2, week 4, week 6, week 8, week 10, week 12, and week 18Population: The study was terminated and data is not reported for privacy reasons
The subjects overall assessment of disease activity from 0-10 cm VAS scale with 0 being no disease and 10 cm being most severe disease
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline, week 2, week 4, week 6, week 8, week 10, week 12, and week 18Population: The study was terminated and data is not reported for privacy reasons
The investigator's or physician's overall assessment of disease activity from 0-10 cm VAS scale with 0 being no disease and 10 cm being most severe disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline, week 4, week 8, week 12, and week 18Population: The study was terminated and data is not reported for privacy reasons
First, precoded numeric values are recoded per the scoring key given in Table 1. Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores. Table 2 lists the items averaged together to create each scale. Items that are left blank(missing data) are not taken into account when calculating the scale scores. Hence, scale scores represent the average for all items in the scale that the respondent answered
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline, week 4, week 8, week 12, and week 18Population: The study was terminated and data is not reported for privacy reasons
The Female Sexual Function Index (FSFI), a 19-item questionnaire, has been developed as a brief, multidimensional self-report instrument for assessing the key dimensions of sexual function in women
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline, week 4, week 8, week 12, and week 18Population: The study was terminated and data is not reported for privacy reasons
Affords calculation of 4 scales to measure the impact of IBD on different domains of impairment in work or other activities: absenteeism, presenteeism (impairment at work), productivity loss (overall work impairment), activity impairment
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Lulizumab (BMS-931699) 12.5mg QW
BMS-986142 350 mg QD
Serious adverse events
| Measure |
Placebo
n=7 participants at risk
Subjects received subcutaneous (SC) injection of placebo matched to 12.5 milligram (mg) lulizumab (BMS-931699) weekly (QW) and oral tablets of placebo matched to 350 mg BMS-986142 once daily (QD) for 12 weeks.
|
Lulizumab (BMS-931699) 12.5mg QW
n=5 participants at risk
Subjects received SC injection of 12.5 mg lulizumab (BMS-931699) QW and oral tablets of placebo matched to 350 mg BMS-986142 QD for 12 weeks.
|
BMS-986142 350 mg QD
n=6 participants at risk
Subjects received oral tablets of 350 mg BMS-986142 QD and placebo matched to SC injection of 12.5 mg lulizumab (BMS-931699) QW for 12 weeks.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/7 • Up to 18 weeks
|
0.00%
0/5 • Up to 18 weeks
|
16.7%
1/6 • Number of events 1 • Up to 18 weeks
|
Other adverse events
| Measure |
Placebo
n=7 participants at risk
Subjects received subcutaneous (SC) injection of placebo matched to 12.5 milligram (mg) lulizumab (BMS-931699) weekly (QW) and oral tablets of placebo matched to 350 mg BMS-986142 once daily (QD) for 12 weeks.
|
Lulizumab (BMS-931699) 12.5mg QW
n=5 participants at risk
Subjects received SC injection of 12.5 mg lulizumab (BMS-931699) QW and oral tablets of placebo matched to 350 mg BMS-986142 QD for 12 weeks.
|
BMS-986142 350 mg QD
n=6 participants at risk
Subjects received oral tablets of 350 mg BMS-986142 QD and placebo matched to SC injection of 12.5 mg lulizumab (BMS-931699) QW for 12 weeks.
|
|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/7 • Up to 18 weeks
|
20.0%
1/5 • Number of events 1 • Up to 18 weeks
|
16.7%
1/6 • Number of events 1 • Up to 18 weeks
|
|
Infections and infestations
Urinary tract infection
|
14.3%
1/7 • Number of events 1 • Up to 18 weeks
|
20.0%
1/5 • Number of events 1 • Up to 18 weeks
|
0.00%
0/6 • Up to 18 weeks
|
|
Infections and infestations
Bronchitis
|
14.3%
1/7 • Number of events 1 • Up to 18 weeks
|
0.00%
0/5 • Up to 18 weeks
|
0.00%
0/6 • Up to 18 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/7 • Up to 18 weeks
|
20.0%
1/5 • Number of events 1 • Up to 18 weeks
|
0.00%
0/6 • Up to 18 weeks
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/7 • Up to 18 weeks
|
20.0%
1/5 • Number of events 1 • Up to 18 weeks
|
0.00%
0/6 • Up to 18 weeks
|
|
Infections and infestations
Influenza
|
0.00%
0/7 • Up to 18 weeks
|
0.00%
0/5 • Up to 18 weeks
|
16.7%
1/6 • Number of events 1 • Up to 18 weeks
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/7 • Up to 18 weeks
|
20.0%
1/5 • Number of events 1 • Up to 18 weeks
|
0.00%
0/6 • Up to 18 weeks
|
|
General disorders
Fatigue
|
0.00%
0/7 • Up to 18 weeks
|
0.00%
0/5 • Up to 18 weeks
|
16.7%
1/6 • Number of events 1 • Up to 18 weeks
|
|
General disorders
Injection site haematoma
|
14.3%
1/7 • Number of events 1 • Up to 18 weeks
|
0.00%
0/5 • Up to 18 weeks
|
0.00%
0/6 • Up to 18 weeks
|
|
General disorders
Injection site reaction
|
0.00%
0/7 • Up to 18 weeks
|
20.0%
1/5 • Number of events 1 • Up to 18 weeks
|
0.00%
0/6 • Up to 18 weeks
|
|
General disorders
Pain
|
0.00%
0/7 • Up to 18 weeks
|
20.0%
1/5 • Number of events 1 • Up to 18 weeks
|
0.00%
0/6 • Up to 18 weeks
|
|
General disorders
Sensation of foreign body
|
0.00%
0/7 • Up to 18 weeks
|
0.00%
0/5 • Up to 18 weeks
|
16.7%
1/6 • Number of events 1 • Up to 18 weeks
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/7 • Up to 18 weeks
|
0.00%
0/5 • Up to 18 weeks
|
16.7%
1/6 • Number of events 2 • Up to 18 weeks
|
|
General disorders
Anticoagulation drug level above therapeutic
|
0.00%
0/7 • Up to 18 weeks
|
0.00%
0/5 • Up to 18 weeks
|
16.7%
1/6 • Number of events 1 • Up to 18 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/7 • Up to 18 weeks
|
0.00%
0/5 • Up to 18 weeks
|
16.7%
1/6 • Number of events 1 • Up to 18 weeks
|
|
Investigations
Blood pressure increased
|
0.00%
0/7 • Up to 18 weeks
|
20.0%
1/5 • Number of events 1 • Up to 18 weeks
|
0.00%
0/6 • Up to 18 weeks
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/7 • Up to 18 weeks
|
20.0%
1/5 • Number of events 1 • Up to 18 weeks
|
0.00%
0/6 • Up to 18 weeks
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/7 • Up to 18 weeks
|
20.0%
1/5 • Number of events 1 • Up to 18 weeks
|
0.00%
0/6 • Up to 18 weeks
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/7 • Up to 18 weeks
|
20.0%
1/5 • Number of events 1 • Up to 18 weeks
|
0.00%
0/6 • Up to 18 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/7 • Up to 18 weeks
|
0.00%
0/5 • Up to 18 weeks
|
16.7%
1/6 • Number of events 1 • Up to 18 weeks
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/7 • Up to 18 weeks
|
0.00%
0/5 • Up to 18 weeks
|
16.7%
1/6 • Number of events 1 • Up to 18 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7 • Up to 18 weeks
|
0.00%
0/5 • Up to 18 weeks
|
16.7%
1/6 • Number of events 1 • Up to 18 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/7 • Up to 18 weeks
|
20.0%
1/5 • Number of events 1 • Up to 18 weeks
|
0.00%
0/6 • Up to 18 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/7 • Up to 18 weeks
|
0.00%
0/5 • Up to 18 weeks
|
16.7%
1/6 • Number of events 1 • Up to 18 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/7 • Up to 18 weeks
|
20.0%
1/5 • Number of events 1 • Up to 18 weeks
|
0.00%
0/6 • Up to 18 weeks
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/7 • Up to 18 weeks
|
0.00%
0/5 • Up to 18 weeks
|
16.7%
1/6 • Number of events 1 • Up to 18 weeks
|
|
Injury, poisoning and procedural complications
Stress fracture
|
14.3%
1/7 • Number of events 1 • Up to 18 weeks
|
0.00%
0/5 • Up to 18 weeks
|
0.00%
0/6 • Up to 18 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • Up to 18 weeks
|
20.0%
1/5 • Number of events 1 • Up to 18 weeks
|
0.00%
0/6 • Up to 18 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/7 • Up to 18 weeks
|
20.0%
1/5 • Number of events 1 • Up to 18 weeks
|
0.00%
0/6 • Up to 18 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/7 • Up to 18 weeks
|
0.00%
0/5 • Up to 18 weeks
|
16.7%
1/6 • Number of events 1 • Up to 18 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/7 • Up to 18 weeks
|
20.0%
1/5 • Number of events 1 • Up to 18 weeks
|
0.00%
0/6 • Up to 18 weeks
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER