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CompletedNCT01023256Updated Oct 24, 2014Results posted

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

A Phase 1/2 interventional study of MOR103 and MOR103 in Rheumatoid Arthritis, sponsored by MorphoSys AG. Completed at 5 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-10-24.

Sponsored by MorphoSys AG · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

GM-CSF is considered to have a key role in the initiation and progression of arthritic inflammation. The purpose of this study is to evaluate the safety, preliminary efficacy, pharmacokinetics, and immunogenicity of multiple doses of MOR103, a human antibody to GM-CSF, in patients with active rheumatoid arthritis.

Read the detailed description

Rheumatoid arthritis (RA) is a chronic systemic inflammatory disease that affects 0.5% to 1% of the adult population world wide. RA primarily affects the joints and is characterized by chronic inflammation of the synovial tissue, which eventually leads to the destruction of cartilage, bone and ligaments and can cause joint deformity.

Pro-inflammatory cytokines, such as tumor necrosis factor-alpha (TNFα), interleukin (IL)-1, IL-6 and granulocyte macrophage colony stimulating factor (GM-CSF), which lead to the activation and proliferation of immune cells, are found to be increased in the inflamed joint. Several preclinical findings support an anti-GM-CSF therapy for RA.

02

Conditions studied

  • Rheumatoid Arthritis

Keywords

  • Rheumatoid arthritis
  • GM-CSF
  • MOR103
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 96 is close to the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

MorphoSys AG is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Rheumatoid arthritis (RA) per revised 1987 ACR criteria
  • Active RA: ≥3 swollen and 3 tender joints with at least 1 swollen joint in the hand, excluding the PIP joint
  • CRP > 5.0 mg/L (RF and anti-CCP seronegative); CRP >2 mg/l (RF and/or anti-CCP seropositive)
  • DAS28 ≤ 5.1
  • Stable regimen of concomitant RA therapy (NSAIDs, steroids, non- biological DMARDs).
  • Negative PPD tuberculin skin test

Exclusion criteria

Exclusion Criteria:

  • Previous therapy with B or T cell depleting agents other than Rituximab (e.g. Campath). Prior treatment with Rituximab, TNF-inhibitors, other biologics (e.g. anti-IL-1 therapy) and systemic immunosuppressive agents is allowed with a washout period.
  • Any history of ongoing, significant or recurring infections
  • Any active inflammatory diseases other than RA
  • Treatment with a systemic investigational drug within 6 months prior to screening
  • Women of childbearing potential, unless receiving stable doses of methotrexate or leflunomide
  • Significant cardiac or pulmonary disease (including methotrexate- associated lung toxicity)
  • Hepatic or renal insufficiency
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
96 participants (actual)

Study arms

  • Experimental
    Group 1: MOR103, experimental

    Biological: MOR103 0.3 mg/kg or placebo

    Drug: MOR103

  • Experimental
    Group 2: MOR103, experimental

    Biological: MOR103 1.0 mg/kg or placebo

    Drug: MOR103

  • Experimental
    Group 3: MOR103, experimental

    Biological: MOR103 1.5 mg/kg or placebo

    Drug: MOR103

Interventions

  • DrugMOR103

    MOR103 0.3 mg/kg or placebo iv x 4 doses

  • DrugMOR103

    MOR103 1.0 mg/kg or placebo iv x 4 doses

  • DrugMOR103

    MOR103 1.5 mg/kg or placebo iv x 4 doses

06

What researchers measure

Primary outcomes

  1. Percentages of Patients With Treatment-emergent or Serious Adverse Events

    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.

    Time frame: From the first dose through the 16-week visit

Secondary outcomes

  1. Change From Baseline in Mean Disease Activity Score-28 Joints (DAS28) at 4 Weeks

    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).

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

  2. Change From Baseline in Mean Disease Activity Score-28 Joints (DAS28) at 8 Weeks

    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)

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

  3. Percentages of Subjects With American College of Rheumatology 20% Improvement (ACR20) at Week 4

    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.

    Time frame: Week 4 (1 week after last MOR103 dose)

  4. Change From Baseline in Mean Swollen and Tender Joint Counts at Weeks 4 and 8

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

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

  5. Change From Baseline in Patient-reported Outcomes at Weeks 4 and 8

    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).

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

Other outcomes

  1. Change From Screening in Outcome Measures in Rheumatology (OMERACT)-Rheumatoid Arthritis Magnetic Resonance Imaging Studies Mean Sum Score for Synovitis at Week 4

    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.

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

  2. Change From Screening in Outcome Measures in Rheumatology (OMERACT)-Rheumatoid Arthritis Magnetic Resonance Imaging Studies Mean Sum Score for Synovitis at Week 8

    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.

    Time frame: Change from screening to week 8

07

Results

Posted May 8, 2014
Limitations and caveats
Key limitations of this trial include its small sample size, limited duration, and exclusion of patients with severe rheumatoid arthritis. Larger clinical trials are needed to confirm these data and define the optimal MOR103 dosage.

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).

Participant flow — Overall Study
MilestoneMOR103 0.3 mg/kgMOR103 1.0 mg/kgMOR103 1.5 mg/kgPooled Placebo
Started25222427
Completed21192322
Not completed4315
Withdrew: Protocol violation2300
Withdrew: Randomized but not treated1010
Withdrew: Other1002
Withdrew: Adverse event0001
Withdrew: Withdrawal by subject0002

Outcome measures

PrimaryPercentages of Patients With Treatment-emergent or Serious Adverse Events

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.

Time frame:
From the first dose through the 16-week visit
Reported as:
Number · percentage of participants
Percentages of Patients With Treatment-emergent or Serious Adverse Events
percentage of participantsMOR103 0.3 mg/kgMOR103 1.0 mg/kgMOR103 1.5 mg/kgPooled ActivePooled Placebo
Percentage with treatment-emergent adverse events54.263.665.260.944.4
Percentage with serious adverse events4.20.00.01.43.7
SecondaryChange From Baseline in Mean Disease Activity Score-28 Joints (DAS28) at 4 Weeks

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).

Time frame:
Change from baseline to week 4 (1 week after last MOR103 dose)
Reported as:
Mean · units on a scale
Change From Baseline in Mean Disease Activity Score-28 Joints (DAS28) at 4 Weeks
units on a scaleMOR103 0.3 mg/kgMOR103 1.0 mg/kgMOR103 1.5 mg/kgPooled Placebo
Change From Baseline in Mean Disease Activity Score-28 Joints (DAS28) at 4 Weeks-0.2 ± 1.1-1.1 ± 0.9-0.6 ± 0.70.2 ± 0.8
Statistical analysis
  • MOR103 0.3 mg/kg vs Pooled Placebo · ANCOVA · p = 0.095 (P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \< 0.05 were considered significant.)The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.
  • MOR103 1.0 mg/kg vs Pooled Placebo · ANCOVA · p = <0.0001 (P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \< 0.05 were considered significant.)The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.
  • MOR103 1.5 mg/kg vs Pooled Placebo · ANCOVA · p = 0.003 (P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \< 0.05 were considered significant.)The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.
Other pre-specifiedChange From Screening in Outcome Measures in Rheumatology (OMERACT)-Rheumatoid Arthritis Magnetic Resonance Imaging Studies Mean Sum Score for Synovitis at Week 4

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.

Time frame:
Change from screening to week 4 (1 week after last MOR103 dose)
Reported as:
Mean · units on a scale
Change From Screening in Outcome Measures in Rheumatology (OMERACT)-Rheumatoid Arthritis Magnetic Resonance Imaging Studies Mean Sum Score for Synovitis at Week 4
units on a scaleMOR103 0.3 mg/kgMOR103 1.0 mg/kgMOR103 1.5 mg/kgPooled Placebo
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 ± 3.09-1.50 ± 2.87-0.50 ± 2.22-0.66 ± 3.09
SecondaryChange From Baseline in Mean Disease Activity Score-28 Joints (DAS28) at 8 Weeks

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)

Time frame:
Change from baseline to week 8 (5 weeks after last MOR103 dose)
Reported as:
Mean · units on a scale
Change From Baseline in Mean Disease Activity Score-28 Joints (DAS28) at 8 Weeks
units on a scaleMOR103 0.3 mg/kgMOR103 1.0 mg/kgMOR103 1.5 mg/kgPooled Placebo
Change From Baseline in Mean Disease Activity Score-28 Joints (DAS28) at 8 Weeks-0.3 ± 0.9-1.0 ± 1.3-0.6 ± 0.9-0.1 ± 0.9
Statistical analysis
  • MOR103 0.3 mg/kg vs Pooled Placebo · ANCOVA · p = 0.421 (P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \< 0.05 were considered significant.)The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.
  • MOR103 1.0 mg/kg vs Pooled Placebo · ANCOVA · p = 0.003 (P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \< 0.05 were considered significant.)The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.
  • MOR103 1.5 mg/kg vs Pooled Placebo · ANCOVA · p = 0.065 (P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values \< 0.05 were considered significant.)The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.
SecondaryPercentages of Subjects With American College of Rheumatology 20% Improvement (ACR20) at Week 4

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.

Time frame:
Week 4 (1 week after last MOR103 dose)
Reported as:
Number · percentage of participants
Percentages of Subjects With American College of Rheumatology 20% Improvement (ACR20) at Week 4
percentage of participantsMOR103 0.3 mg/kgMOR103 1.0 mg/kgMOR103 1.5 mg/kgPooled Placebo
Percentages of Subjects With American College of Rheumatology 20% Improvement (ACR20) at Week 425.068.230.47.4
Statistical analysis
  • MOR103 0.3 mg/kg vs Pooled Placebo · Fisher Exact · p = 0.243 (P values \<0.05 were considered to be statistically significant.)Patients with missing values were not included
  • MOR103 1.0 mg/kg vs Pooled Placebo · Fisher Exact · p = <0.0001 (P values \< 0.05 were considered significant.)Patients with missing values were not included
  • MOR103 1.5 mg/kg vs Pooled Placebo · Fisher Exact · p = 0.135 (P values \<0.05 were considered to be statistically significant.)Patients with missing values were not included.
SecondaryChange From Baseline in Mean Swollen and Tender Joint Counts at Weeks 4 and 8

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

Time frame:
Change from baseline to week 4 (1 week after last MOR103 dose) and change from baseline to week 8
Reported as:
Mean · joints
Change From Baseline in Mean Swollen and Tender Joint Counts at Weeks 4 and 8
jointsMOR103 0.3 mg/kgMOR103 1.0 mg/kgMOR103 1.5 mg/kgPooled Placebo
Change in swollen joint count at week 4-1.7 ± 2.4-3.5 ± 5.1-3.3 ± 3.20.1 ± 3.5
Change in swollen joint count at week 8-1.9 ± 2.2-4.1 ± 4.4-3.3 ± 3.1-0.8 ± 3.6
Change in tender joint count at week 40.1 ± 7.1-4.8 ± 3.2-3.7 ± 6.22.0 ± 6.4
Change in tender joint count at week 80.3 ± 5.0-6.8 ± 4.1-4.0 ± 5.32.1 ± 8.0
SecondaryChange From Baseline in Patient-reported Outcomes at Weeks 4 and 8

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).

Time frame:
Change from baseline at week 4 (1 week after last MOR103 dose) and change from baseline at week 8
Reported as:
Mean · units on a scale
Change From Baseline in Patient-reported Outcomes at Weeks 4 and 8
units on a scaleMOR103 0.3 mg/kgMOR103 1.0 mg/kgMOR103 1.5 mg/kgPooled Placebo
Change in pain at week 4-8.6 ± 22.8-17.4 ± 17.2-11.4 ± 11.5-3.3 ± 16.5
Change in pain at week 8-4.1 ± 23.1-13.4 ± 20.9-9.5 ± 11.9-8.0 ± 16.1
Change in HAQ-DI at week 4-0.21 ± 0.41-0.53 ± 0.52-0.31 ± 0.24-0.45 ± 0.54
Change in HAQ-DI at week 8-0.21 ± 0.56-0.51 ± 0.56-0.25 ± 0.22-0.44 ± 0.54
Change in patient global assessment at week 4-2.7 ± 20.5-16.6 ± 15.6-6.0 ± 17.7-3.0 ± 16.1
Change in patient global assessment at week 8-4.5 ± 21.9-13.3 ± 24.7-4.0 ± 8.3-8.2 ± 17.5
Change in FACIT fatigue score at week 42.7 ± 9.29.1 ± 10.23.1 ± 6.03.0 ± 8.1
Change in FACIT fatigue score at week 82.1 ± 5.69.4 ± 12.64.7 ± 7.14.3 ± 9.1
Other pre-specifiedChange From Screening in Outcome Measures in Rheumatology (OMERACT)-Rheumatoid Arthritis Magnetic Resonance Imaging Studies Mean Sum Score for Synovitis at Week 8

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.

Time frame:
Change from screening to week 8
Reported as:
Mean · units on a scale
Change From Screening in Outcome Measures in Rheumatology (OMERACT)-Rheumatoid Arthritis Magnetic Resonance Imaging Studies Mean Sum Score for Synovitis at Week 8
units on a scaleMOR103 0.3 mg/kgMOR103 1.0 mg/kgMOR103 1.5 mg/kgPooled Placebo
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 ± 3.49-0.90 ± 2.83-1.00 ± 2.73-0.91 ± 3.06

Adverse events

Collected over 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.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
MOR103 0.3 mg/kg—1/24 (4.2%)11/24 (45.8%)
MOR103 1.0 mg/kg—0/22 (0%)22/22 (100%)
MOR103 1.5 mg/kg—0/23 (0%)14/23 (60.9%)
Pooled Active—1/69 (1.4%)47/69 (68.1%)
Pooled Placebo—1/27 (3.7%)12/27 (44.4%)
Most frequent serious events
Most frequent serious events
EventMOR103 0.3 mg/kgMOR103 1.0 mg/kgMOR103 1.5 mg/kgPooled ActivePooled Placebo
PleurisyRespiratory, thoracic and mediastinal disorders1/240/220/231/690/27
ParonychiaInfections and infestations0/240/220/230/691/27
Most frequent other events
Showing 10 of 13
Most frequent other events
EventMOR103 0.3 mg/kgMOR103 1.0 mg/kgMOR103 1.5 mg/kgPooled ActivePooled Placebo
NasopharyngitisInfections and infestations1/247/221/239/693/27
Rheumatoid arthritisMusculoskeletal and connective tissue disorders3/244/222/239/690/27
FatigueGeneral disorders1/244/221/236/691/27
RashSkin and subcutaneous tissue disorders1/240/220/231/693/27
RhinitisInfections and infestations0/242/220/232/690/27
Oropharyngeal painRespiratory, thoracic and mediastinal disorders0/242/220/232/691/27
HypertensionVascular disorders1/242/222/235/691/27
Viral respiratory tract infectionInfections and infestations0/240/222/232/690/27
CoughRespiratory, thoracic and mediastinal disorders1/240/222/233/690/27
HeadacheNervous system disorders1/240/222/233/691/27

Baseline characteristics

All baseline participants were included in baseline analyses.

Age, Continuous
Age, Continuous(years)MOR103 0.3 mg/kgMOR103 1.0 mg/kgMOR103 1.5 mg/kgPooled PlaceboTotal
Mean57.4 ± 8.349.0 ± 12.753.0 ± 9.953.8 ± 12.753.4 ± 11.3
Sex: Female, Male
Sex: Female, Male(Participants)MOR103 0.3 mg/kgMOR103 1.0 mg/kgMOR103 1.5 mg/kgPooled PlaceboTotal
Female2117181975
Male355821
Region of Enrollment
Region of Enrollment(participants)MOR103 0.3 mg/kgMOR103 1.0 mg/kgMOR103 1.5 mg/kgPooled PlaceboTotal
Poland843823
Ukraine0413724
Bulgaria1274629
Netherlands00123
Germany472417
Body mass index
Body mass index(kg/m2)MOR103 0.3 mg/kgMOR103 1.0 mg/kgMOR103 1.5 mg/kgPooled PlaceboTotal
Mean26.3 ± 3.626.1 ± 4.625.7 ± 4.726.3 ± 3.526.1 ± 4.1
Disease Activity Score based on 28 joints and erythrocyte sedimentation rate (DAS28-ESR)
Disease Activity Score based on 28 joints and erythrocyte sedimentation rate (DAS28-ESR)(units on a scale)MOR103 0.3 mg/kgMOR103 1.0 mg/kgMOR103 1.5 mg/kgPooled PlaceboTotal
Mean4.88 ± 0.544.78 ± 0.664.87 ± 0.384.88 ± 0.414.86 ± 0.50
Rheumatoid factor (RF) status
Rheumatoid factor (RF) status(participants)MOR103 0.3 mg/kgMOR103 1.0 mg/kgMOR103 1.5 mg/kgPooled PlaceboTotal
RF positive2119192584
RF negative324110
Missing01012
Prior medication with non-biologic disease-modifying antirheumatic drugs (DMARDs)
Prior medication with non-biologic disease-modifying antirheumatic drugs (DMARDs)(participants)MOR103 0.3 mg/kgMOR103 1.0 mg/kgMOR103 1.5 mg/kgPooled PlaceboTotal
Treated with prior non-biologic DMARDs1815202174
Not treated with prior non-biologic DMARDs673622
Prior medication with tumor necrosis factor (TNF) inhibitors
Prior medication with tumor necrosis factor (TNF) inhibitors(participants)MOR103 0.3 mg/kgMOR103 1.0 mg/kgMOR103 1.5 mg/kgPooled PlaceboTotal
Treated with prior TNF inhibitors10023
Not treated with prior TNF inhibitors2322232593

1 further baseline measures are reported on the registry.

08

Study locations

5 sites
  • MorphoSys Investigative sites
    MorphoSys Investigative sites, Bulgaria
  • MorphoSys Investigative sites
    MorphoSys Investigative sites, Germany
  • MorphoSys Investigative sites
    MorphoSys Investigative sites, Netherlands
  • MorphoSys Investigative sites
    MorphoSys Investigative sites, Poland
  • MorphoSys Investigative sites
    MorphoSys investigatíve sites, Ukraine
09

References and documents

Publications

  • Behrens F, Tak PP, Ostergaard M, Stoilov R, Wiland P, Huizinga TW, Berenfus VY, Vladeva S, Rech J, Rubbert-Roth A, Korkosz M, Rekalov D, Zupanets IA, Ejbjerg BJ, Geiseler J, Fresenius J, Korolkiewicz RP, Schottelius AJ, Burkhardt H. MOR103, a human monoclonal antibody to granulocyte-macrophage colony-stimulating factor, in the treatment of patients with moderate rheumatoid arthritis: results of a phase Ib/IIa randomised, double-blind, placebo-controlled, dose-escalation trial. Ann Rheum Dis. 2015 Jun;74(6):1058-64. doi: 10.1136/annrheumdis-2013-204816. Epub 2014 Feb 17. PubMed 24534756 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01023256
Lead sponsor
MorphoSys AG
Responsible party
Sponsor
First posted
Dec 2, 2009
Start date
Dec 2009
Primary completion
Jun 2012
Completion
Jun 2012
Results posted
May 8, 2014
Last update
Oct 24, 2014

Study contacts

Roman P Korolkiewicz, MD, PhD
study director · MorphoSys AG

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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