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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: MOR103, experimental | Experimental | Biological: MOR103 0.3 mg/kg or placebo |
|
| Group 2: MOR103, experimental | Experimental | Biological: MOR103 1.0 mg/kg or placebo |
|
| Group 3: MOR103, experimental | Experimental | Biological: MOR103 1.5 mg/kg or placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MOR103 | Drug | MOR103 0.3 mg/kg or placebo iv x 4 doses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the first dose through the 16-week visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Change from baseline to week 4 (1 week after last MOR103 dose) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roman P Korolkiewicz, MD, PhD | MorphoSys AG | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MorphoSys Investigative sites | MorphoSys Investigative Sites | Bulgaria | ||||
| MorphoSys Investigative sites |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24534756 | Result | 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. |
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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.
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | MOR103 0.3 mg/kg | MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses) |
| FG001 | MOR103 1.0 mg/kg | MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses) |
| FG002 | MOR103 1.5 mg/kg | MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses) |
| FG003 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All baseline participants were included in baseline analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | MOR103 0.3 mg/kg | MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses) |
| BG001 | MOR103 1.0 mg/kg | MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All patients who received treatment. | Posted | Number | percentage of participants | From the first dose through the 16-week visit |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MOR103 0.3 mg/kg | MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Paronychia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roman Korolkiewicz | MorphoSys | +498989927 | 208 | Roman.Korolkiewicz@morphosys.com |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C000599766 | Otilimab |
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| MOR103 |
| Drug |
MOR103 1.0 mg/kg or placebo iv x 4 doses |
|
| MOR103 | Drug | MOR103 1.5 mg/kg or placebo iv x 4 doses |
|
| 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) | Change from baseline to week 8 (5 weeks after last MOR103 dose) |
| 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. | Week 4 (1 week after last MOR103 dose) |
| 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. | Change from baseline to week 4 (1 week after last MOR103 dose) and change from baseline to week 8 |
| 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). | Change from baseline at week 4 (1 week after last MOR103 dose) and change from baseline at week 8 |
| Change from screening to week 4 (1 week after last MOR103 dose) |
| 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. | Change from screening to week 8 |
| 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 |
| Randomized but not treated |
|
| Other |
|
| Adverse Event |
|
| Withdrawal by Subject |
|
| BG002 | MOR103 1.5 mg/kg | MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses) |
| BG003 | 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). |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index | Mean | Standard Deviation | kg/m2 |
|
| Disease Activity Score based on 28 joints and erythrocyte sedimentation rate (DAS28-ESR) | The Disease Activity Score is a measure of overall disease activity and was 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). In the MOR103 1.0 mg/kg group, one patient had missing data so the mean was calculated on 21 patients. | Mean | Standard Deviation | units on a scale |
|
| Rheumatoid factor (RF) status | Defined as RF levels >13.9 IU/mL. One patient in the MOR103 1.0 mg/kg group and one patient in the pooled placebo group had missing data. | Number | participants |
|
| Prior medication with non-biologic disease-modifying antirheumatic drugs (DMARDs) | Medication with non-biologic disease-modifying drugs in the 3 months prior to screening | Number | participants |
|
| Prior medication with tumor necrosis factor (TNF) inhibitors | Medication with tumour necrosis factor inhibitors in the 3 months prior to screening | Number | participants |
|
| Concomitant medication with non-biologic disease-modifying antirheumatic drugs (DMARDs) | Concomitant medication with non-biologic disease-modifying antirheumatic drugs at baseline | Number | participants |
|
MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
| OG002 | MOR103 1.5 mg/kg | MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses) |
| OG003 | Pooled Active | All patients receiving MOR103 at any dose |
| OG004 | 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). |
|
|
| Secondary | 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). | All treated patients | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to week 4 (1 week after last MOR103 dose) |
|
|
|
|
| Other Pre-specified | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Change from screening to week 4 (1 week after last MOR103 dose) |
|
|
|
| Secondary | 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) | All treated patients | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to week 8 (5 weeks after last MOR103 dose) |
|
|
|
|
| Secondary | 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. | 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. | Posted | Number | percentage of participants | Week 4 (1 week after last MOR103 dose) |
|
|
|
|
| Secondary | 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. | All treated patients | Posted | Mean | Standard Deviation | joints | Change from baseline to week 4 (1 week after last MOR103 dose) and change from baseline to week 8 |
|
|
|
| Secondary | 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). | All treated patients | Posted | Mean | Standard Deviation | units on a scale | Change from baseline at week 4 (1 week after last MOR103 dose) and change from baseline at week 8 |
|
|
|
| Other Pre-specified | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Change from screening to week 8 |
|
|
|
| 1 |
| 24 |
| 11 |
| 24 |
| EG001 | MOR103 1.0 mg/kg | MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses) | 0 | 22 | 22 | 22 |
| EG002 | MOR103 1.5 mg/kg | MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses) | 0 | 23 | 14 | 23 |
| EG003 | Pooled Active | All patients receiving MOR103 at any dose | 1 | 69 | 47 | 69 |
| EG004 | Pooled Placebo | 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) | 1 | 27 | 12 | 27 |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Viral respiratory tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment | Worsening or flares of rheumatoid arthritis. In 8 of the 9 MOR103 subjects with RA exacerbations, this AE occurred after the last dose of MOR103 (10 days to >12 weeks), suggesting that disease flares were related to withdrawal of active treatment. |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Edema peripheral | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Carbon monoxide diffusing capacity decreased | Investigations | MedDRA 13.0 | Systematic Assessment | Based on investigator reports of clinically relevant events. |
|
| Hypertension | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment | Includes patients with preferred term "rash" and preferred term "rash maculo-papular" |
|
| Anemia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
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.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| ANCOVA |
The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline. |
| <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. |
| No |
| Superiority or Other |
| ANCOVA | The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline. | 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. | No | Superiority or Other |
| ANCOVA |
The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline. |
| 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. |
| No |
| Superiority or Other |
| ANCOVA | The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline. | 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. | No | Superiority or Other |
Patients with missing values were not included |
| <0.0001 |
P values < 0.05 were considered significant. |
| No |
| Superiority or Other |
| Fisher Exact | Patients with missing values were not included. | 0.135 | P values <0.05 were considered to be statistically significant. | No | Superiority or Other |
| Change in swollen joint count at week 8 |
|
| Change in tender joint count at week 4 |
|
| Change in tender joint count at week 8 |
|
| Change in pain at week 8 |
|
| Change in HAQ-DI at week 4 |
|
| Change in HAQ-DI at week 8 |
|
| Change in patient global assessment at week 4 |
|
| Change in patient global assessment at week 8 |
|
| Change in FACIT fatigue score at week 4 |
|
| Change in FACIT fatigue score at week 8 |
|