Trial Outcomes & Findings for Safety and Preliminary Efficacy of MOR103 in Patients With Active Rheumatoid Arthritis (NCT NCT01023256)

Last Updated: 2014-10-24

Results Overview

Data on treatment-emergent adverse events (MedDRA version 13.0) were collected at each visit (weeks 1, 2, 3, 4, 5, 6, 8, 10, 13, and 16). For a list of serious adverse events and adverse events occurring at a frequency of \>5 % (\>1 patient) in any treatment group, please see the adverse events listing.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

96 participants

Primary outcome timeframe

From the first dose through the 16-week visit

Results posted on

2014-10-24

Participant Flow

Subjects were recruited and screened between January 19, 2010 and February 9, 2012 at rheumatology centers in Europe (Bulgaria, Germany, the Netherlands, Poland and Ukraine).

Subject eligibility was determined at the screening visit (up to 35 days before treatment initiation) and confirmed at baseline before the first dose on day 1.

Participant milestones

Participant milestones
Measure	MOR103 0.3 mg/kg MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)	MOR103 1.0 mg/kg MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)	MOR103 1.5 mg/kg MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)	Pooled Placebo All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses)
Overall Study STARTED	25	22	24	27
Overall Study COMPLETED	21	19	23	22
Overall Study NOT COMPLETED	4	3	1	5

Reasons for withdrawal

Reasons for withdrawal
Measure	MOR103 0.3 mg/kg MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)	MOR103 1.0 mg/kg MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)	MOR103 1.5 mg/kg MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)	Pooled Placebo All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses)
Overall Study Protocol Violation	2	3	0	0
Overall Study Randomized but not treated	1	0	1	0
Overall Study Other	1	0	0	2
Overall Study Adverse Event	0	0	0	1
Overall Study Withdrawal by Subject	0	0	0	2

Baseline Characteristics

Safety and Preliminary Efficacy of MOR103 in Patients With Active Rheumatoid Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MOR103 0.3 mg/kg n=24 Participants MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)	MOR103 1.0 mg/kg n=22 Participants MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)	MOR103 1.5 mg/kg n=23 Participants MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)	Pooled Placebo n=27 Participants All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).	Total n=96 Participants Total of all reporting groups
Age, Continuous	57.4 years STANDARD_DEVIATION 8.3 • n=5 Participants	49.0 years STANDARD_DEVIATION 12.7 • n=7 Participants	53.0 years STANDARD_DEVIATION 9.9 • n=5 Participants	53.8 years STANDARD_DEVIATION 12.7 • n=4 Participants	53.4 years STANDARD_DEVIATION 11.3 • n=21 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	17 Participants n=7 Participants	18 Participants n=5 Participants	19 Participants n=4 Participants	75 Participants n=21 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	8 Participants n=4 Participants	21 Participants n=21 Participants
Region of Enrollment Poland	8 participants n=5 Participants	4 participants n=7 Participants	3 participants n=5 Participants	8 participants n=4 Participants	23 participants n=21 Participants
Region of Enrollment Ukraine	0 participants n=5 Participants	4 participants n=7 Participants	13 participants n=5 Participants	7 participants n=4 Participants	24 participants n=21 Participants
Region of Enrollment Bulgaria	12 participants n=5 Participants	7 participants n=7 Participants	4 participants n=5 Participants	6 participants n=4 Participants	29 participants n=21 Participants
Region of Enrollment Netherlands	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants	3 participants n=21 Participants
Region of Enrollment Germany	4 participants n=5 Participants	7 participants n=7 Participants	2 participants n=5 Participants	4 participants n=4 Participants	17 participants n=21 Participants
Body mass index	26.3 kg/m2 STANDARD_DEVIATION 3.6 • n=5 Participants	26.1 kg/m2 STANDARD_DEVIATION 4.6 • n=7 Participants	25.7 kg/m2 STANDARD_DEVIATION 4.7 • n=5 Participants	26.3 kg/m2 STANDARD_DEVIATION 3.5 • n=4 Participants	26.1 kg/m2 STANDARD_DEVIATION 4.1 • n=21 Participants
Disease Activity Score based on 28 joints and erythrocyte sedimentation rate (DAS28-ESR)	4.88 units on a scale STANDARD_DEVIATION 0.54 • n=5 Participants	4.78 units on a scale STANDARD_DEVIATION 0.66 • n=7 Participants	4.87 units on a scale STANDARD_DEVIATION 0.38 • n=5 Participants	4.88 units on a scale STANDARD_DEVIATION 0.41 • n=4 Participants	4.86 units on a scale STANDARD_DEVIATION 0.50 • n=21 Participants
Rheumatoid factor (RF) status RF positive	21 participants n=5 Participants	19 participants n=7 Participants	19 participants n=5 Participants	25 participants n=4 Participants	84 participants n=21 Participants
Rheumatoid factor (RF) status RF negative	3 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants	1 participants n=4 Participants	10 participants n=21 Participants
Rheumatoid factor (RF) status Missing	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	2 participants n=21 Participants
Prior medication with non-biologic disease-modifying antirheumatic drugs (DMARDs) Treated with prior non-biologic DMARDs	18 participants n=5 Participants	15 participants n=7 Participants	20 participants n=5 Participants	21 participants n=4 Participants	74 participants n=21 Participants
Prior medication with non-biologic disease-modifying antirheumatic drugs (DMARDs) Not treated with prior non-biologic DMARDs	6 participants n=5 Participants	7 participants n=7 Participants	3 participants n=5 Participants	6 participants n=4 Participants	22 participants n=21 Participants
Prior medication with tumor necrosis factor (TNF) inhibitors Treated with prior TNF inhibitors	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants	3 participants n=21 Participants
Prior medication with tumor necrosis factor (TNF) inhibitors Not treated with prior TNF inhibitors	23 participants n=5 Participants	22 participants n=7 Participants	23 participants n=5 Participants	25 participants n=4 Participants	93 participants n=21 Participants
Concomitant medication with non-biologic disease-modifying antirheumatic drugs (DMARDs) Treated with concomitant non-biologic DMARDs	22 participants n=5 Participants	17 participants n=7 Participants	21 participants n=5 Participants	26 participants n=4 Participants	86 participants n=21 Participants
Concomitant medication with non-biologic disease-modifying antirheumatic drugs (DMARDs) Not treated with concomitant non-biologic DMARDs	2 participants n=5 Participants	5 participants n=7 Participants	2 participants n=5 Participants	1 participants n=4 Participants	10 participants n=21 Participants

PRIMARY outcome

Timeframe: From the first dose through the 16-week visit

Population: All patients who received treatment.

Outcome measures

Outcome measures
Measure	MOR103 0.3 mg/kg n=24 Participants MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)	MOR103 1.0 mg/kg n=22 Participants MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)	MOR103 1.5 mg/kg n=23 Participants MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)	Pooled Active n=69 Participants All patients receiving MOR103 at any dose	Pooled Placebo n=27 Participants All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
Percentages of Patients With Treatment-emergent or Serious Adverse Events Percentage with treatment-emergent adverse events	54.2 percentage of participants	63.6 percentage of participants	65.2 percentage of participants	60.9 percentage of participants	44.4 percentage of participants
Percentages of Patients With Treatment-emergent or Serious Adverse Events Percentage with serious adverse events	4.2 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	1.4 percentage of participants	3.7 percentage of participants

SECONDARY outcome

Timeframe: Change from baseline to week 4 (1 week after last MOR103 dose)

Population: All treated patients

The primary exploratory efficacy outcome was change from baseline in Disease Activity Score calculated using 28 joints (DAS28) and the erythrocyte sedimentation rate (ESR) as the acute phase reactant (0 = no disease activity; 9.3 = maximal disease activity).

Outcome measures

Outcome measures
Measure	MOR103 0.3 mg/kg n=24 Participants MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)	MOR103 1.0 mg/kg n=22 Participants MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)	MOR103 1.5 mg/kg n=23 Participants MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)	Pooled Active n=27 Participants All patients receiving MOR103 at any dose	Pooled Placebo All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
Change From Baseline in Mean Disease Activity Score-28 Joints (DAS28) at 4 Weeks	-0.2 units on a scale Standard Deviation 1.1	-1.1 units on a scale Standard Deviation 0.9	-0.6 units on a scale Standard Deviation 0.7	0.2 units on a scale Standard Deviation 0.8	—

SECONDARY outcome

Timeframe: Change from baseline to week 8 (5 weeks after last MOR103 dose)

Population: All treated patients

Outcome measures

Outcome measures
Measure	MOR103 0.3 mg/kg n=24 Participants MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)	MOR103 1.0 mg/kg n=22 Participants MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)	MOR103 1.5 mg/kg n=23 Participants MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)	Pooled Active n=27 Participants All patients receiving MOR103 at any dose	Pooled Placebo All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
Change From Baseline in Mean Disease Activity Score-28 Joints (DAS28) at 8 Weeks	-0.3 units on a scale Standard Deviation 0.9	-1.0 units on a scale Standard Deviation 1.3	-0.6 units on a scale Standard Deviation 0.9	-0.1 units on a scale Standard Deviation 0.9	—

SECONDARY outcome

Timeframe: Week 4 (1 week after last MOR103 dose)

Population: All participants were included in ACR response calculations. Patients lacking data required for calculation of an ACR response were considered as not having an ACR response. 1 patient in the MOR103 0.3 mg/kg group, 1 patient in the MOR103 1.0 mg/kg group, and 5 patients in the pooled placebo group had missing data for ACR calculations.

The percentage of patients achieving an ACR20 response (20% improvement based on ACR improvement criteria) in each group. ACR20 improvement criteria require at least 20% improvement in both swollen and tender joints counts and 3 out of 5 of the following parameters: pain visual analog scale, patient global assessment, physician global assessment, acute phase reactant (erythrocyte sedimentation rate or C-reactive protein), and functional questionnaire.

Outcome measures

Outcome measures
Measure	MOR103 0.3 mg/kg n=24 Participants MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)	MOR103 1.0 mg/kg n=22 Participants MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)	MOR103 1.5 mg/kg n=23 Participants MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)	Pooled Active n=27 Participants All patients receiving MOR103 at any dose	Pooled Placebo All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
Percentages of Subjects With American College of Rheumatology 20% Improvement (ACR20) at Week 4	25.0 percentage of participants	68.2 percentage of participants	30.4 percentage of participants	7.4 percentage of participants	—

SECONDARY outcome

Timeframe: Change from baseline to week 4 (1 week after last MOR103 dose) and change from baseline to week 8

Population: All treated patients

Swollen joint counts were based on 66 joints and tender joint counts were based on 69 joints.

Outcome measures

Outcome measures
Measure	MOR103 0.3 mg/kg n=24 Participants MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)	MOR103 1.0 mg/kg n=22 Participants MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)	MOR103 1.5 mg/kg n=23 Participants MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)	Pooled Active n=27 Participants All patients receiving MOR103 at any dose	Pooled Placebo All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
Change From Baseline in Mean Swollen and Tender Joint Counts at Weeks 4 and 8 Change in swollen joint count at week 4	-1.7 joints Standard Deviation 2.4	-3.5 joints Standard Deviation 5.1	-3.3 joints Standard Deviation 3.2	0.1 joints Standard Deviation 3.5	—
Change From Baseline in Mean Swollen and Tender Joint Counts at Weeks 4 and 8 Change in tender joint count at week 8	0.3 joints Standard Deviation 5.0	-6.8 joints Standard Deviation 4.1	-4.0 joints Standard Deviation 5.3	2.1 joints Standard Deviation 8.0	—
Change From Baseline in Mean Swollen and Tender Joint Counts at Weeks 4 and 8 Change in swollen joint count at week 8	-1.9 joints Standard Deviation 2.2	-4.1 joints Standard Deviation 4.4	-3.3 joints Standard Deviation 3.1	-0.8 joints Standard Deviation 3.6	—
Change From Baseline in Mean Swollen and Tender Joint Counts at Weeks 4 and 8 Change in tender joint count at week 4	0.1 joints Standard Deviation 7.1	-4.8 joints Standard Deviation 3.2	-3.7 joints Standard Deviation 6.2	2.0 joints Standard Deviation 6.4	—

SECONDARY outcome

Timeframe: Change from baseline at week 4 (1 week after last MOR103 dose) and change from baseline at week 8

Population: All treated patients

Patient-reported outcomes included patient's self-assessment of pain (measured on a 100 mm visual analogue scale \[VAS\] from 0 = best to 100 = worst), the Health Assessment Questionnaire-Disability Index (HAQ-DI; 0 = best to 3 = worst), the patient's global assessment of disease activity (measured on a 100 mm visual analogue scale \[VAS\] from 0 = best to 100 = worst), and fatigue, which was measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue self-assessment scale (0 = worst; 52 = best).

Outcome measures

Outcome measures
Measure	MOR103 0.3 mg/kg n=24 Participants MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)	MOR103 1.0 mg/kg n=22 Participants MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)	MOR103 1.5 mg/kg n=23 Participants MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)	Pooled Active n=27 Participants All patients receiving MOR103 at any dose	Pooled Placebo All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
Change From Baseline in Patient-reported Outcomes at Weeks 4 and 8 Change in pain at week 4	-8.6 units on a scale Standard Deviation 22.8	-17.4 units on a scale Standard Deviation 17.2	-11.4 units on a scale Standard Deviation 11.5	-3.3 units on a scale Standard Deviation 16.5	—
Change From Baseline in Patient-reported Outcomes at Weeks 4 and 8 Change in pain at week 8	-4.1 units on a scale Standard Deviation 23.1	-13.4 units on a scale Standard Deviation 20.9	-9.5 units on a scale Standard Deviation 11.9	-8.0 units on a scale Standard Deviation 16.1	—
Change From Baseline in Patient-reported Outcomes at Weeks 4 and 8 Change in HAQ-DI at week 4	-0.21 units on a scale Standard Deviation 0.41	-0.53 units on a scale Standard Deviation 0.52	-0.31 units on a scale Standard Deviation 0.24	-0.45 units on a scale Standard Deviation 0.54	—
Change From Baseline in Patient-reported Outcomes at Weeks 4 and 8 Change in HAQ-DI at week 8	-0.21 units on a scale Standard Deviation 0.56	-0.51 units on a scale Standard Deviation 0.56	-0.25 units on a scale Standard Deviation 0.22	-0.44 units on a scale Standard Deviation 0.54	—
Change From Baseline in Patient-reported Outcomes at Weeks 4 and 8 Change in patient global assessment at week 4	-2.7 units on a scale Standard Deviation 20.5	-16.6 units on a scale Standard Deviation 15.6	-6.0 units on a scale Standard Deviation 17.7	-3.0 units on a scale Standard Deviation 16.1	—
Change From Baseline in Patient-reported Outcomes at Weeks 4 and 8 Change in patient global assessment at week 8	-4.5 units on a scale Standard Deviation 21.9	-13.3 units on a scale Standard Deviation 24.7	-4.0 units on a scale Standard Deviation 8.3	-8.2 units on a scale Standard Deviation 17.5	—
Change From Baseline in Patient-reported Outcomes at Weeks 4 and 8 Change in FACIT fatigue score at week 4	2.7 units on a scale Standard Deviation 9.2	9.1 units on a scale Standard Deviation 10.2	3.1 units on a scale Standard Deviation 6.0	3.0 units on a scale Standard Deviation 8.1	—
Change From Baseline in Patient-reported Outcomes at Weeks 4 and 8 Change in FACIT fatigue score at week 8	2.1 units on a scale Standard Deviation 5.6	9.4 units on a scale Standard Deviation 12.6	4.7 units on a scale Standard Deviation 7.1	4.3 units on a scale Standard Deviation 9.1	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from screening to week 4 (1 week after last MOR103 dose)

Population: At week 4, MRI data were not available for 5 placebo patients, 2 MOR103 0.3 mg/kg patients, 2 MOR103 1.0 mg/kg patients, and 1 MOR103 1.5 mg/kg patient.

Magnetic resonance imaging (MRI) was performed on the wrist and hand on the side with the most swollen joints (or the right side if swollen joints were equivalent). The 2nd to 5th metacarpophalangeal joints and 3 wrist joints (distal radioulnar, radiocarpal, and intercarpal-carpometacarpal joints) were scored on a scale of 0 = no synovitis to 3 = severe synovitis. MRIs were scored by 2 independent experts blinded to patient data and chronology. The sum score is the average of the 2 reader scores for each of the 7 joints. The range of the sum score is thus 0 = no synovitis in any joint to 21 = severe synovitis in all joints.

Outcome measures

Outcome measures
Measure	MOR103 0.3 mg/kg n=22 Participants MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)	MOR103 1.0 mg/kg n=20 Participants MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)	MOR103 1.5 mg/kg n=22 Participants MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)	Pooled Active n=22 Participants All patients receiving MOR103 at any dose	Pooled Placebo All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
Change From Screening in Outcome Measures in Rheumatology (OMERACT)-Rheumatoid Arthritis Magnetic Resonance Imaging Studies Mean Sum Score for Synovitis at Week 4	-0.37 units on a scale Standard Deviation 3.09	-1.50 units on a scale Standard Deviation 2.87	-0.50 units on a scale Standard Deviation 2.22	-0.66 units on a scale Standard Deviation 3.09	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from screening to week 8

Population: At week 8, MRI data were not available for 6 placebo patients, 5 MOR103 0.3 mg/kg patients, 1 MOR103 1.0 mg/kg patient, and 2 MOR103 1.5 mg/kg patients.

Outcome measures

Outcome measures
Measure	MOR103 0.3 mg/kg n=19 Participants MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)	MOR103 1.0 mg/kg n=21 Participants MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)	MOR103 1.5 mg/kg n=21 Participants MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)	Pooled Active n=21 Participants All patients receiving MOR103 at any dose	Pooled Placebo All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
Change From Screening in Outcome Measures in Rheumatology (OMERACT)-Rheumatoid Arthritis Magnetic Resonance Imaging Studies Mean Sum Score for Synovitis at Week 8	-0.48 units on a scale Standard Deviation 3.49	-0.90 units on a scale Standard Deviation 2.83	-1.00 units on a scale Standard Deviation 2.73	-0.91 units on a scale Standard Deviation 3.06	—

Adverse Events

MOR103 0.3 mg/kg

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

MOR103 1.0 mg/kg

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

MOR103 1.5 mg/kg

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Pooled Active

Serious events: 1 serious events

Other events: 47 other events

Deaths: 0 deaths

Pooled Placebo

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MOR103 0.3 mg/kg n=24 participants at risk MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)	MOR103 1.0 mg/kg n=22 participants at risk MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)	MOR103 1.5 mg/kg n=23 participants at risk MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)	Pooled Active n=69 participants at risk All patients receiving MOR103 at any dose	Pooled Placebo n=27 participants at risk Pooled placebo group included all patients who were randomized to placebo in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses)
Infections and infestations Paronychia	0.00% 0/24 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	0.00% 0/22 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	0.00% 0/23 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	0.00% 0/69 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	3.7% 1/27 • Number of events 1 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.
Respiratory, thoracic and mediastinal disorders Pleurisy	4.2% 1/24 • Number of events 1 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	0.00% 0/22 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	0.00% 0/23 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	1.4% 1/69 • Number of events 1 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	0.00% 0/27 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.

Other adverse events

Other adverse events
Measure	MOR103 0.3 mg/kg n=24 participants at risk MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)	MOR103 1.0 mg/kg n=22 participants at risk MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)	MOR103 1.5 mg/kg n=23 participants at risk MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)	Pooled Active n=69 participants at risk All patients receiving MOR103 at any dose	Pooled Placebo n=27 participants at risk Pooled placebo group included all patients who were randomized to placebo in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses)
Infections and infestations Nasopharyngitis	4.2% 1/24 • Number of events 2 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	31.8% 7/22 • Number of events 7 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	4.3% 1/23 • Number of events 1 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	13.0% 9/69 • Number of events 10 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	11.1% 3/27 • Number of events 3 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.
Infections and infestations Viral respiratory tract infection	0.00% 0/24 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	0.00% 0/22 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	8.7% 2/23 • Number of events 2 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	2.9% 2/69 • Number of events 2 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	0.00% 0/27 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.
Infections and infestations Rhinitis	0.00% 0/24 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	9.1% 2/22 • Number of events 2 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	0.00% 0/23 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	2.9% 2/69 • Number of events 2 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	0.00% 0/27 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	12.5% 3/24 • Number of events 3 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	18.2% 4/22 • Number of events 4 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	8.7% 2/23 • Number of events 3 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	13.0% 9/69 • Number of events 10 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	0.00% 0/27 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.
Respiratory, thoracic and mediastinal disorders Cough	4.2% 1/24 • Number of events 1 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	0.00% 0/22 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	8.7% 2/23 • Number of events 2 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	4.3% 3/69 • Number of events 3 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	0.00% 0/27 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/24 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	9.1% 2/22 • Number of events 2 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	0.00% 0/23 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	2.9% 2/69 • Number of events 2 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	3.7% 1/27 • Number of events 1 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.
General disorders Fatigue	4.2% 1/24 • Number of events 1 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	18.2% 4/22 • Number of events 5 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	4.3% 1/23 • Number of events 1 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	8.7% 6/69 • Number of events 7 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	3.7% 1/27 • Number of events 1 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.
General disorders Edema peripheral	0.00% 0/24 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	4.5% 1/22 • Number of events 1 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	0.00% 0/23 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	1.4% 1/69 • Number of events 1 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	7.4% 2/27 • Number of events 2 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.
Investigations Carbon monoxide diffusing capacity decreased	8.3% 2/24 • Number of events 2 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	0.00% 0/22 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	0.00% 0/23 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	2.9% 2/69 • Number of events 2 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	7.4% 2/27 • Number of events 2 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.
Vascular disorders Hypertension	4.2% 1/24 • Number of events 1 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	9.1% 2/22 • Number of events 2 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	8.7% 2/23 • Number of events 2 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	7.2% 5/69 • Number of events 5 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	3.7% 1/27 • Number of events 1 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.
Nervous system disorders Headache	4.2% 1/24 • Number of events 1 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	0.00% 0/22 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	8.7% 2/23 • Number of events 2 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	4.3% 3/69 • Number of events 3 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	3.7% 1/27 • Number of events 2 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.
Skin and subcutaneous tissue disorders Rash	4.2% 1/24 • Number of events 1 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	0.00% 0/22 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	0.00% 0/23 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	1.4% 1/69 • Number of events 1 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	11.1% 3/27 • Number of events 3 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.
Blood and lymphatic system disorders Anemia	0.00% 0/24 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	0.00% 0/22 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	8.7% 2/23 • Number of events 2 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	2.9% 2/69 • Number of events 2 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.	0.00% 0/27 • All treatment-emergent adverse events reported from the time of the first dose of MOR103 or placebo to the end of the 16-week follow up period.

Additional Information

Roman Korolkiewicz

MorphoSys

Phone: +498989927

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All information supplied by MorphoSys is considered confidential until publication and shall not be disclosed without prior written consent from MorphoSys. No data can be published in any format without prior approval of the MSC-1001 Publication Committee, which has final decision on approving submissions for publication. In the event of disagreement in the content of a publication, both the Author's and MorphoSys' opinion will be fairly and sufficiently represented in the publication.
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