Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)
Trial · NCT04333147
Outcomes42
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 42
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) | Up to approximately 145 Weeks | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Hematology Parameter of Platelet Count at Week 24 | Baseline (Day 01) and Week 24 | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Giga cells per liter (10^9 cells/L) | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameter of Platelet Count at Week 48 | Baseline (Day 01) and Week 48 | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Giga cells per liter (10^9 cells/L) | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameter of Platelet Count at Week 96 | Baseline (Day 01) and Week 96 | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Giga cells per liter (10^9 cells/L) | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameter of Platelet Count at Week 144 | Baseline (Day 01) and Week 144 | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Giga cells per liter (10^9 cells/L) | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameter of Hemoglobin at Week 24 | Baseline (Day 01) and Week 24 | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Gram Per Liter (g/L) | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameter of Hemoglobin at Week 48 | Baseline (Day 01) and Week 48 | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Gram Per Liter (g/L) | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameter of Hemoglobin at Week 96 | Baseline (Day 01) and Week 96 | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Gram Per Liter (g/L) | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameter of Hemoglobin at Week 144 | Baseline (Day 01) and Week 144 | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Gram Per Liter (g/L) | MEAN |
| PRIMARY | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 24 | Baseline (Day 01) and Week 24 | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Giga cells per liter (10^9 cells/L) | MEAN |
| PRIMARY | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 48 | Baseline (Day 01) and Week 48 | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Giga cells per liter (10^9 cells/L) | MEAN |
| PRIMARY | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 96 | Baseline (Day 01) and Week 96 | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Giga cells per liter (10^9 cells/L) | MEAN |
| PRIMARY | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 144 | Baseline (Day 01) and Week 144 | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Giga cells per liter (10^9 cells/L) | MEAN |
| PRIMARY | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 24 | Baseline (Day 01) and Week 24 | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | International units per liter (IU/L) | MEAN |
| PRIMARY | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 48 | Baseline (Day 01) and Week 48 | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | International units per liter (IU/L) | MEAN |
| PRIMARY | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 96 | Baseline (Day 01) and Week 96 | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | International units per liter (IU/L) | MEAN |
| PRIMARY | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 144 | Baseline (Day 01) and Week 144 | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | International units per liter (IU/L) | MEAN |
| PRIMARY | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 24 | Baseline (Day 01) and Week 24 | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Millimoles per liter (mmol/L) | MEAN |
| PRIMARY | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 48 | Baseline (Day 01) and Week 48 | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Millimoles per liter (mmol/L) | MEAN |
| PRIMARY | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 96 | Baseline (Day 01) and Week 96 | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Millimoles per liter (mmol/L) | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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