Trial Outcomes & Findings for 99mTc-rhAnnexin V-128 a Phase I/IIa Study in Patients With Rheumatoid Arthritis (RA) or Ankylosing Spondylitis (AS) (NCT NCT02328027)

Last Updated: 2020-10-08

Results Overview

An adverse event (AE) is defined as any untoward medical occurrence in a patient and which does not necessarily have a causal relationship with the study medication. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease, temporally associated with the use of a study medication, whether or not causally related to the study medication. TEAEs are defined as all AEs reported after the first dose. An SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, life-threatening, results in persistent or significant disability/incapacity, results in congenital anomaly or birth defect, requires in-patient hospitalization or leads to prolongation of hospitalization.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

16 participants

Primary outcome timeframe

From screening up to Day 90

Results posted on

2020-10-08

Participant Flow

It was planned that 20 evaluable patients with either RA or AS (enrolled in a 1:1 ratio) would be included and would complete the assessments on Day 56, however recruitment was terminated after inclusion of 16 patients.

Of the 16 enrolled participants, 10 participants would take part in a PK/dosimetric sub-study, after providing written approval (only 5 participants were enrolled to the sub-study). Of the first 6 enrolled participants overall, at least 3 had to take part in the sub-study to optimise the PK time points for subsequent participants .

Participant milestones

Participant milestones
Measure	99mTc-rhAnnexin V-128: Ankylosing Spondylitis Participants with Ankylosing Spondylitis (AS) received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 Megabecquerel (MBq) through an intravenous (IV) catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42.	99mTc-rhAnnexin V-128: Rheumatoid Arthritis Participants with Rheumatoid Arthritis (RA) received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42.
Overall Study STARTED	5	11
Overall Study COMPLETED	5	10
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	99mTc-rhAnnexin V-128: Ankylosing Spondylitis Participants with Ankylosing Spondylitis (AS) received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 Megabecquerel (MBq) through an intravenous (IV) catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42.	99mTc-rhAnnexin V-128: Rheumatoid Arthritis Participants with Rheumatoid Arthritis (RA) received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42.
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

99mTc-rhAnnexin V-128 a Phase I/IIa Study in Patients With Rheumatoid Arthritis (RA) or Ankylosing Spondylitis (AS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	99mTc-rhAnnexin V-128: Ankylosing Spondylitis n=5 Participants Participants with AS received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42.	99mTc-rhAnnexin V-128: Rheumatoid Arthritis n=11 Participants Participants with RA received received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42.	Total n=16 Participants Total of all reporting groups
Age, Continuous	43.2 Years STANDARD_DEVIATION 10.73 • n=5 Participants	51.6 Years STANDARD_DEVIATION 18.74 • n=7 Participants	49.0 Years STANDARD_DEVIATION 16.77 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	4 Participants n=5 Participants	11 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment Switzerland	5 Participants n=5 Participants	11 Participants n=7 Participants	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: From screening up to Day 90

Population: Safety analysis set included all participants who have received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	99mTc-rhAnnexin V-128: Ankylosing Spondylitis n=5 Participants Participants with AS received received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42.	99mTc-rhAnnexin V-128: Rheumatoid Arthritis n=11 Participants Participants with RA received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42.
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAE) and Death TEAEs	3 Participants	11 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAE) and Death SAEs	0 Participants	1 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAE) and Death Death	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 (0 (Predose), 0.05, 0.10, 0.15, 0.30, 1.00, 1.50, 2.00, 4.00 and 24.00 hours)

Population: PK population included all participants who participated in the PK/dosimetry sub-study which included participants regardless of their diagnosis (RA or AS). Here 'n' (number analyzed) signifies participants who were evaluable for specified categories.

AUC is defined as area under the curve extrapolated to infinity of 99mTc-rhAnnexin V-128.

Outcome measures

Outcome measures
Measure	99mTc-rhAnnexin V-128: Ankylosing Spondylitis n=5 Participants Participants with AS received received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42.	99mTc-rhAnnexin V-128: Rheumatoid Arthritis Participants with RA received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42.
Area Under the Curve Extrapolated to Infinity (AUC) of 99mTc-rhAnnexin V-128 Blood	41.2 nanogram*hour per milliliter (ng.h/mL) Standard Deviation 13.7	—
Area Under the Curve Extrapolated to Infinity (AUC) of 99mTc-rhAnnexin V-128 Serum	53.6 nanogram*hour per milliliter (ng.h/mL) Standard Deviation 22.6	—

SECONDARY outcome

Timeframe: Day 1 (0 (Predose), 0.05, 0.10, 0.15, 0.30, 1.00, 1.50, 2.00, 4.00 and 24.00 hours)

Vz is defined as the distribution volume of 99mTc-rhAnnexin V-128.

Outcome measures

Outcome measures
Measure	99mTc-rhAnnexin V-128: Ankylosing Spondylitis n=5 Participants Participants with AS received received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42.	99mTc-rhAnnexin V-128: Rheumatoid Arthritis Participants with RA received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42.
Distribution Volume (Vz) of 99mTc-rhAnnexin V-128 Blood	30.3 Liters (L) Standard Deviation 9.0	—
Distribution Volume (Vz) of 99mTc-rhAnnexin V-128 Serum	26.1 Liters (L) Standard Deviation 11.5	—

SECONDARY outcome

Timeframe: Day 1 (0 (Predose), 0.05, 0.10, 0.15, 0.30, 1.00, 1.50, 2.00, 4.00 and 24.00 hours)

Cl is defined as the systemic clearance of 99mTc-rhAnnexin V-128.

Outcome measures

Outcome measures
Measure	99mTc-rhAnnexin V-128: Ankylosing Spondylitis n=5 Participants Participants with AS received received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42.	99mTc-rhAnnexin V-128: Rheumatoid Arthritis Participants with RA received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42.
Systemic Clearance (Cl) of 99mTc-rhAnnexin V-128 Blood	5.82 Liter per hour (L/h) Standard Deviation 1.59	—
Systemic Clearance (Cl) of 99mTc-rhAnnexin V-128 Serum	4.68 Liter per hour (L/h) Standard Deviation 1.67	—

SECONDARY outcome

Timeframe: Day 1 (0 (Predose), 0.05, 0.10, 0.15, 0.30, 1.00, 1.50, 2.00, 4.00 and 24.00 hours)

t1/2 is defined as the elimination half-life of 99mTc-rhAnnexin V-128.

Outcome measures

Outcome measures
Measure	99mTc-rhAnnexin V-128: Ankylosing Spondylitis n=5 Participants Participants with AS received received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42.	99mTc-rhAnnexin V-128: Rheumatoid Arthritis Participants with RA received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42.
Elimination Half-life (t1/2) of 99mTc-rhAnnexin V-128 Blood	3.6 hours Standard Deviation 0.2	—
Elimination Half-life (t1/2) of 99mTc-rhAnnexin V-128 Serum	3.8 hours Standard Deviation 0.3	—

SECONDARY outcome

Timeframe: Day 1 (0 (Predose), 0.05, 0.10, 0.15, 0.30, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00 and 24.00 hours)

Population: Pharmacokinetic (PK) population included all participants who participated in the PK/dosimetry sub-study which included participants regardless of their diagnosis (RA or AS). Due to low concentration of the protein in serum PK parameters could not be derived.

Serum concentration of rhAnnexin V-128 based on ELISA analysis were to be evaluated and reported overtime.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 (0 (Predose), 0.05, 0.10, 0.15, 0.30, 1.00, 1.50 to 2.00, 3.00 to 4.00 and 24.00 hours)

Total radioactivity count per minute in whole blood samples were reported.

Outcome measures

Outcome measures
Measure	99mTc-rhAnnexin V-128: Ankylosing Spondylitis n=5 Participants Participants with AS received received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42.	99mTc-rhAnnexin V-128: Rheumatoid Arthritis Participants with RA received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42.
99mTc-rhAnnexin V-128 Blood Cpm Decay Corrected Data (Counts Per Minute in 1 mL Sample) 0 (Predose)	0.0 counts per minute (CPM) in 1 mL sample Standard Deviation 0.00	—
99mTc-rhAnnexin V-128 Blood Cpm Decay Corrected Data (Counts Per Minute in 1 mL Sample) 5 min	1667814 counts per minute (CPM) in 1 mL sample Standard Deviation 209478	—
99mTc-rhAnnexin V-128 Blood Cpm Decay Corrected Data (Counts Per Minute in 1 mL Sample) 10 min	1188917 counts per minute (CPM) in 1 mL sample Standard Deviation 162265	—
99mTc-rhAnnexin V-128 Blood Cpm Decay Corrected Data (Counts Per Minute in 1 mL Sample) 15 min	976977 counts per minute (CPM) in 1 mL sample Standard Deviation 168240	—
99mTc-rhAnnexin V-128 Blood Cpm Decay Corrected Data (Counts Per Minute in 1 mL Sample) 30 min	560111 counts per minute (CPM) in 1 mL sample Standard Deviation 183995	—
99mTc-rhAnnexin V-128 Blood Cpm Decay Corrected Data (Counts Per Minute in 1 mL Sample) 1h	270715 counts per minute (CPM) in 1 mL sample Standard Deviation 101320	—
99mTc-rhAnnexin V-128 Blood Cpm Decay Corrected Data (Counts Per Minute in 1 mL Sample) 1.5h to 2.0h	140730 counts per minute (CPM) in 1 mL sample Standard Deviation 30842	—
99mTc-rhAnnexin V-128 Blood Cpm Decay Corrected Data (Counts Per Minute in 1 mL Sample) 3.0h to 4.0h	64421 counts per minute (CPM) in 1 mL sample Standard Deviation 20850	—
99mTc-rhAnnexin V-128 Blood Cpm Decay Corrected Data (Counts Per Minute in 1 mL Sample) 24h	1803 counts per minute (CPM) in 1 mL sample Standard Deviation 641	—

SECONDARY outcome

Timeframe: Day 1 (0 (Predose), 0.05, 0.10, 0.15, 0.30, 1.00, 1.50 to 2.00, 3.00 to 4.00, 6.00 and 24.00 hours)

Total radioactivity count per minute in serum samples were reported.

Outcome measures

Outcome measures
Measure	99mTc-rhAnnexin V-128: Ankylosing Spondylitis n=5 Participants Participants with AS received received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42.	99mTc-rhAnnexin V-128: Rheumatoid Arthritis Participants with RA received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42.
99mTc-rhAnnexin V-128 Serum Cpm Decay Corrected Data (Counts Per Minute in 1 mL Sample) Predose	0.0 counts per minute (CPM) in 1 mL sample Standard Deviation 0.00	—
99mTc-rhAnnexin V-128 Serum Cpm Decay Corrected Data (Counts Per Minute in 1 mL Sample) 5 min	2043946 counts per minute (CPM) in 1 mL sample Standard Deviation 654557	—
99mTc-rhAnnexin V-128 Serum Cpm Decay Corrected Data (Counts Per Minute in 1 mL Sample) 10 min	1432102 counts per minute (CPM) in 1 mL sample Standard Deviation 453282	—
99mTc-rhAnnexin V-128 Serum Cpm Decay Corrected Data (Counts Per Minute in 1 mL Sample) 15 min	1176933 counts per minute (CPM) in 1 mL sample Standard Deviation 299437	—
99mTc-rhAnnexin V-128 Serum Cpm Decay Corrected Data (Counts Per Minute in 1 mL Sample) 30 min	719880 counts per minute (CPM) in 1 mL sample Standard Deviation 287310	—
99mTc-rhAnnexin V-128 Serum Cpm Decay Corrected Data (Counts Per Minute in 1 mL Sample) 1h	349309 counts per minute (CPM) in 1 mL sample Standard Deviation 103963	—
99mTc-rhAnnexin V-128 Serum Cpm Decay Corrected Data (Counts Per Minute in 1 mL Sample) 1.5h to 2.0h	223067 counts per minute (CPM) in 1 mL sample Standard Deviation 51303	—
99mTc-rhAnnexin V-128 Serum Cpm Decay Corrected Data (Counts Per Minute in 1 mL Sample) 3.0h to 4.0h	106070 counts per minute (CPM) in 1 mL sample Standard Deviation 31082	—
99mTc-rhAnnexin V-128 Serum Cpm Decay Corrected Data (Counts Per Minute in 1 mL Sample) 6h	56768 counts per minute (CPM) in 1 mL sample Standard Deviation NA NA: Not estimable due to the number of participants with events.	—
99mTc-rhAnnexin V-128 Serum Cpm Decay Corrected Data (Counts Per Minute in 1 mL Sample) 24h	3126 counts per minute (CPM) in 1 mL sample Standard Deviation 1010	—

SECONDARY outcome

Timeframe: Day 1 (0 (Predose), 1.00, 4.00, 6.00 and 24.00 hours)

Total radioactivity count per minute in urine samples were reported.

Outcome measures

Outcome measures
Measure	99mTc-rhAnnexin V-128: Ankylosing Spondylitis n=5 Participants Participants with AS received received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42.	99mTc-rhAnnexin V-128: Rheumatoid Arthritis Participants with RA received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42.
99mTc-rhAnnexin V-128 Urine Cpm Decay Corrected Data (Counts Per Minute in 1 mL Sample) 0 (Predose)	12 counts per minute (CPM) in 1 mL sample Standard Deviation 26	—
99mTc-rhAnnexin V-128 Urine Cpm Decay Corrected Data (Counts Per Minute in 1 mL Sample) 1 hour	6613620 counts per minute (CPM) in 1 mL sample Standard Deviation 1786521	—
99mTc-rhAnnexin V-128 Urine Cpm Decay Corrected Data (Counts Per Minute in 1 mL Sample) 4 hours	9135076 counts per minute (CPM) in 1 mL sample Standard Deviation 3248412	—
99mTc-rhAnnexin V-128 Urine Cpm Decay Corrected Data (Counts Per Minute in 1 mL Sample) 16 hours	1517263 counts per minute (CPM) in 1 mL sample Standard Deviation 1180019	—
99mTc-rhAnnexin V-128 Urine Cpm Decay Corrected Data (Counts Per Minute in 1 mL Sample) 24 hours	96155.2 counts per minute (CPM) in 1 mL sample Standard Deviation 84394.79	—

SECONDARY outcome

Timeframe: Day 1 (0 (Predose), up to 1.00 hour, from 1.00 to 4.00 hours, from 4.00 to 6.00 hours, from 16.00 to 24.00 hours)

Population: PK population included all participants who participated in the PK/dosimetry sub-study which included participants regardless of their diagnosis (RA or AS).

Urine samples (10 mL aliquots) were analysed as a function of time by SEC-HPLC technique at the local laboratory in order to gain information on the chemical status of 99mTc-rhAnnexin V-128 and on the presence of 99mTc-rhAnnexin V-128-related species.

Outcome measures

Outcome measures
Measure	99mTc-rhAnnexin V-128: Ankylosing Spondylitis n=5 Participants Participants with AS received received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42.	99mTc-rhAnnexin V-128: Rheumatoid Arthritis Participants with RA received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42.
Number of Annexin Related Species as Assessed Size-Exclusion HPLC- High-Performance Liquid Chromatography (SEC-HPLC) Analysis 0 (Predose)-HPLC Performed?=Yes · Species found = No	5 Participants	—
Number of Annexin Related Species as Assessed Size-Exclusion HPLC- High-Performance Liquid Chromatography (SEC-HPLC) Analysis 0 (Predose)-HPLC Performed?=Yes · Species found = Not Specified	0 Participants	—
Number of Annexin Related Species as Assessed Size-Exclusion HPLC- High-Performance Liquid Chromatography (SEC-HPLC) Analysis Up to 1 hour-HPLC Performed?=Yes · Species found = No	5 Participants	—
Number of Annexin Related Species as Assessed Size-Exclusion HPLC- High-Performance Liquid Chromatography (SEC-HPLC) Analysis Up to 1 hour-HPLC Performed?=Yes · Species found = Not Specified	0 Participants	—
Number of Annexin Related Species as Assessed Size-Exclusion HPLC- High-Performance Liquid Chromatography (SEC-HPLC) Analysis From 1 to 4 hours-HPLC Performed?=Yes · Species found = No	5 Participants	—
Number of Annexin Related Species as Assessed Size-Exclusion HPLC- High-Performance Liquid Chromatography (SEC-HPLC) Analysis From 1 to 4 hours-HPLC Performed?=Yes · Species found = Not Specified	0 Participants	—
Number of Annexin Related Species as Assessed Size-Exclusion HPLC- High-Performance Liquid Chromatography (SEC-HPLC) Analysis From 4 to 6 hours-HPLC Performed?=Yes · Species found = No	5 Participants	—
Number of Annexin Related Species as Assessed Size-Exclusion HPLC- High-Performance Liquid Chromatography (SEC-HPLC) Analysis From 4 to 6 hours-HPLC Performed?=Yes · Species found = Not Specified	0 Participants	—
Number of Annexin Related Species as Assessed Size-Exclusion HPLC- High-Performance Liquid Chromatography (SEC-HPLC) Analysis From 16 to 24 hours-HPLC Performed?=Yes · Species found = No	4 Participants	—
Number of Annexin Related Species as Assessed Size-Exclusion HPLC- High-Performance Liquid Chromatography (SEC-HPLC) Analysis From 16 to 24 hours-HPLC Performed?=Yes · Species found = Not Specified	0 Participants	—
Number of Annexin Related Species as Assessed Size-Exclusion HPLC- High-Performance Liquid Chromatography (SEC-HPLC) Analysis From 16 to 24 hours-HPLC Performed?=No · Species found = No	0 Participants	—
Number of Annexin Related Species as Assessed Size-Exclusion HPLC- High-Performance Liquid Chromatography (SEC-HPLC) Analysis From 16 to 24 hours-HPLC Performed?=No · Species found = Not Specified	1 Participants	—

Adverse Events

99mTc-rhAnnexin V-128: Ankylosing Spondylitis

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

99mTc-rhAnnexin V-128: Rheumatoid Arthritis

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	99mTc-rhAnnexin V-128: Ankylosing Spondylitis n=5 participants at risk Participants with AS received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42.	99mTc-rhAnnexin V-128: Rheumatoid Arthritis n=11 participants at risk Participants with RA received received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42.
Psychiatric disorders Depression	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.

Other adverse events

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	99mTc-rhAnnexin V-128: Ankylosing Spondylitis n=5 participants at risk Participants with AS received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42.	99mTc-rhAnnexin V-128: Rheumatoid Arthritis n=11 participants at risk Participants with RA received received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42.
Cardiac disorders Angina pectoris	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Cardiac disorders Cyanosis	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Cardiac disorders Palpitations	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Gastrointestinal disorders Abdominal pain upper	20.0% 1/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	0.00% 0/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Gastrointestinal disorders Dry mouth	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Gastrointestinal disorders Faeces discoloured	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Gastrointestinal disorders Haematochezia	20.0% 1/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	0.00% 0/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Gastrointestinal disorders Nausea	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	18.2% 2/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Gastrointestinal disorders Vomiting	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
General disorders Chills	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
General disorders Fatigue	40.0% 2/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	36.4% 4/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
General disorders Influenza like illness	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	18.2% 2/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
General disorders Malaise	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
General disorders Pain	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
General disorders Pyrexia	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	18.2% 2/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Immune system disorders Cytokine release syndrome	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Infections and infestations Gastroenteritis	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Infections and infestations Infection	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Infections and infestations Nasopharyngitis	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Infections and infestations Urinary tract infection	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	18.2% 2/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Injury, poisoning and procedural complications Fall	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Injury, poisoning and procedural complications Procedural dizziness	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Investigations Blood urine present	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Investigations Oxygen saturation decreased	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Investigations Weight decreased	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Investigations Weight increased	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	27.3% 3/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Nervous system disorders Cognitive disorder	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Nervous system disorders Dementia	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Nervous system disorders Paraesthesia	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	27.3% 3/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Nervous system disorders Paresis	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Psychiatric disorders Depression	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Renal and urinary disorders Dysuria	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Renal and urinary disorders Pollakiuria	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Renal and urinary disorders Urinary incontinence	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Renal and urinary disorders Urinary tract pain	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Renal and urinary disorders Urine odour abnormal	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	27.3% 3/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Skin and subcutaneous tissue disorders Hyperhidrosis	20.0% 1/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	0.00% 0/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Skin and subcutaneous tissue disorders Skin disorder	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Vascular disorders Hypertension	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.
Vascular disorders Hypotension	0.00% 0/5 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.	9.1% 1/11 • From start of screening up to Day 90 Safety set included all eligible participants who were administered at least one treatment.