cometadata/datacite-titles-descriptions-related-identifiers huggingface dataset:
DOI: 10.25934/pr00008703
title: Randomized, Double-blind, Placebo-controlled, Multicenter, Phase IIb Dose Finding Study of GLPG0634 Administered for 24 Weeks in Combination With Methotrexate to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Alone

description: Participants suffering from active rheumatoid arthritis despite continued treatment with methotrexate were evaluated for improvement of disease activity (efficacy) when taking GLPG0634 (3 different doses - 50 milligram [mg], 100 mg and 200 mg daily -, each evaluated as once daily [QD] and twice daily [BID] regimen) or matching placebo for 24 weeks. •During the course of the study, patients were also examined for any side effects that could occur (safety and tolerability), and the amount of GLPG0634 present in the blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood (Pharmacodynamics) were determined. Also, the effects of different doses and dose regiments of GLPG0634 administration on participants' disability, fatigue, and quality of life were evaluated.
DOI: 10.25934/pr00008704
title: Randomized, Double-blind, Placebo-controlled, Multicenter, Phase IIb Dose Finding Study of GLPG0634 Administered for 24 Weeks as Monotherapy to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate (MTX) Alone

description: -  Participants suffering from active rheumatoid arthritis who had an inadequate response to methotrexate were evaluated for improvement of disease activity (efficacy) when taking GLPG0634 as monotherapy (3 different doses - 50 milligram (mg), 100 mg and 200 mg once daily) or matching placebo for 24 weeks.   -  During the course of the study, patients were also examined for any side effects that could occur (safety and tolerability), and the amount of GLPG0634 present in the blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood (Pharmacodynamics) were determined. Also, the effects of different doses of GLPG0634 administration on participants' disability, fatigue and quality of life were evaluated.
DOI: 10.5067/modis/mcd43d39.006
title: MCD43D39 MODIS/Terra+Aqua BRDF/Albedo QA ValidobsBand7 Daily L3 Global 30ArcSec CMG V006
DOI: 10.25934/pr00008705
title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 Weeks in Combination With Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment

description: The primary objective of this study is to evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the percentage of participants achieving an American College of Rheumatology 20% improvement response (ACR20) at Week 12.
DOI: 10.25934/pr00008707
title: A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination With Methotrexate (MTX) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy

description: The primary objective of this study is to evaluate the effects of filgotinib in combination with methotrexate (MTX) versus MTX alone in adults with active rheumatoid arthritis (RA).
DOI: 10.5067/modis/mcd43d40.006
title: MCD43D40 MODIS/Terra+Aqua BRDF/Albedo QA SnowStatus Daily L3 Global 30ArcSec CMG V006
DOI: 10.25934/pr00008708
title: A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks in Combination With Methotrexate to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

description: The primary objective of this study is to evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the percentage of participants achieving an American College of Rheumatology 20% improvement response (ACR20) at Week 12.
DOI: 10.5067/modis/mcd43d41.006
title: MCD43D41 MODIS/Terra+Aqua BRDF/Albedo QA Uncertainty Daily L3 Global 30ArcSec CMG V006
DOI: 10.5067/modis/mcd43d42.006
title: MCD43D42 MODIS/Terra+Aqua BRDF/Albedo Black Sky Albedo Band1 Daily L3 Global 30ArcSec CMG V006
DOI: 10.25934/pr00011071
title: A Multi-center Double-blind Parallel-group Placebo-controlled Study of the Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis

description: The primary objective of the study was to assess the effect of two doses of teriflunomide, in comparison to placebo, on the frequency of multiple sclerosis (MS) relapses in participants with relapsing MS.Key secondary objective was to assess the effect of the two doses of teriflunomide, in comparison to placebo, on disability progression.Other secondary objectives were:* To assess the effect of the two doses of teriflunomide in comparison to placebo on:  * Fatigue;  * Health-related quality of life, a measure of the impact of the participant's health on his or her overall well being.* To evaluate the safety and tolerability of teriflunomide.
DOI: 10.25934/pr00011072
title: A Multi-center, Randomized, Parallel-group, Rater-blinded Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis Plus a Long Term Extension Period

description: Primary objective was to assess the effectiveness evaluated by the time to failure of two doses of teriflunomide in comparison to interferon beta-1a in participants with relapsing Multiple Sclerosis \[MS\].Secondary objectives were:* To assess the effect of the two doses in comparison to interferon beta-1a on:  * Frequency of relapses,  * Fatigue,  * Participant's satisfaction with treatment.* To evaluate the safety and tolerability of the two doses in comparison to interferon beta-1a.The study consisted of a core treatment period with a common end date defined as 48 weeks after randomization of the last participant, followed by an optional long-term extension treatment period until teriflunomide is commercially available in accordance with local regulations.
DOI: 10.5067/modis/mcd43d43.006
title: MCD43D43 MODIS/Terra+Aqua BRDF/Albedo Black Sky Albedo Band2 Daily L3 Global 30ArcSec CMG V006
DOI: 10.25934/pr00011073
title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Design Study to Evaluate the Efficacy and Safety of Teriflunomide in Reducing the Frequency of Relapses and Delaying the Accumulation of Physical Disability in Subjects With Multiple Sclerosis With Relapses

description: The primary objective was to determine the effect of teriflunomide on the frequency of relapses in patients with relapsing multiple sclerosis (MS).Secondary objectives were:* to evaluate the effect of teriflunomide on the accumulation of disability as measured by Expanded Disability Status Scale \[EDSS\], the burden of disease as measured by Magnetic Resonance Imaging \[MRI\] and patient-reported fatigue;* to evaluate the safety and tolerability of teriflunomide.
DOI: 10.25934/pr00011074
title: A Multi-center Double-blind Parallel-group Placebo-controlled Study of the Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis Who Are Treated With Interferon-beta

description: The primary objective was to demonstrate the effect of teriflunomide, in comparison to placebo, on frequency of Multiple Sclerosis (MS) relapses in patients with relapsing forms of MS who are treated with Interferon-beta (IFN-beta).The secondary objectives were:* Assess the effect of teriflunomide, in comparison to placebo, when added to IFN-beta on:  * Disease activity as measured by brain Magnetic Resonance Imaging (MRI)  * Disability progression  * Burden of disease and disease progression as measured by brain MRI* Evaluate the safety and tolerability of teriflunomide when added to IFN-beta therapy* Assess the pharmacokinetics of teriflunomide in use in addition to baseline IFN-beta therapy* Assess associations between variations in genes and clinical outcomes (safety and efficacy)* Assess other measures of efficacy of teriflunomide such as fatigue and health-related quality of life* Assess measures of health economics (hospitalization due to relapse, including the length of stay and any admission to intensive care unit)
DOI: 10.5067/modis/mcd43d44.006
title: MCD43D44 MODIS/Terra+Aqua BRDF/Albedo Black Sky Albedo Band3 Daily L3 Global 30ArcSec CMG V006
DOI: 10.25934/pr00011075
title: An International, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Year Treatment With Teriflunomide 7 mg Once Daily and 14 mg Once Daily Versus Placebo in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis Plus a Long Term Extension Period

description: The primary objective was to demonstrate the effect of teriflunomide (HMR1726) (14 milligram per day \[mg/day\] and 7 mg/day), in comparison to placebo, for reducing conversion of participants presenting with their first clinical episode consistent with multiple sclerosis (MS) to clinically definite multiple sclerosis (CDMS).The secondary objectives were:* To demonstrate the effect of teriflunomide, in comparison to placebo, on:  * Reducing conversion to definite multiple sclerosis (DMS)  * Reducing annualized relapse rate (ARR)  * Reducing disease activity/progression as measured by Magnetic Resonance Imaging (MRI)  * Reducing accumulation of disability for at least 12 weeks as measured by the Expanded Disability Status Scale (EDSS)  * Proportion of disability-free participants as assessed by the EDSS  * Reducing participant-reported fatigue* To evaluate the safety and tolerability of teriflunomide* To evaluate the pharmacokinetics (PK) of teriflunomide* Optional pharmacogenomic testing aimed at assessing the association between the main enzyme systems of teriflunomide metabolism and hepatic safety, and other potential associations between gene variations and clinical outcomes
DOI: 10.25934/pr00011076
title: Long-term Extension of the Multinational, Double-blind, Placebo Controlled Study EFC6049 (HMR1726D/3001) to Document the Safety of Two Doses of Teriflunomide (7 and 14 mg) in Patients With Multiple Sclerosis With Relapses

description: The primary objective of this study was to document the long-term safety and tolerability of teriflunomide in Multiple Sclerosis (MS) participants with relapse.The secondary objective was to document the long-term efficacy on disability progression, relapse rate and Magnetic Resonance Imaging (MRI) parameters.
DOI: 10.5067/modis/mcd43d45.006
title: MCD43D45 MODIS/Terra+Aqua BRDF/Albedo Black Sky Albedo Band4 Daily L3 Global 30ArcSec CMG V006
DOI: 10.25934/pr00011077
title: Exploratory Open Label Study to Investigate the Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Relapsing Forms of Multiple Sclerosis

description: Primary Objective:To measure the effect of Teriflunomide on lymphocytes subsets in patients with relapsing forms of multiple sclerosis as compared with baseline values and those of a reference population of untreated healthy subjects.Secondary Objectives:To assess if Teriflunomide treatment results in biased T cell clonal diversity. To assess the effect of Teriflunomide on the function of peripheral blood mononuclear cells (proliferation and cytokine production in situ).To assess the circulating cytokines profile in the serum of Relapsing Multiple Sclerosis (RMS) patients during a 24-week treatment versus baseline and healthy controls.To assess the reversibility of all parameter changes in patients who discontinue treatment after accelerated elimination procedure with cholestyramine or activated charcoal.
DOI: 10.5067/modis/mcd43d46.006
title: MCD43D46 MODIS/Terra+Aqua BRDF/Albedo Black Sky Albedo Band5 Daily L3 Global 30ArcSec CMG V006
DOI: 10.25934/pr00011078
title: A Prospective, Single-Arm, Clinical-Setting Study to Describe Efficacy, Tolerability and Convenience of Teriflunomide Treatment Using Patient Reported Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients

description: Primary Objective:To describe efficacy, tolerability and convenience of teriflunomide treatment through the evaluation of Participant Reported Outcomes (PROs).Secondary Objectives:To describe disease progression using PROs. To describe clinical outcomes (ie, treated relapses) in teriflunomide treated participant.To describe the change in cognition in teriflunomide treated participants. To describe safety of teriflunomide in participant treated (based on adverse events reporting).To describe adherence and persistence to teriflunomide treatment. To describe quality of life, activity and leisure over the period of teriflunomide treatment.To compare Participant Determined Disease Steps (PDDS) and Expanded Disability Status Scale (EDSS) in assessing Multiple Sclerosis (MS) disease progression.
DOI: 10.25934/pr00011079
title: A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients With Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension

description: Primary Objective:To assess the effect of teriflunomide in comparison to placebo on disease activity measured by time to first clinical relapse after randomization in children and adolescents 10 to 17 years of age with relapsing forms of multiple sclerosis (MS).Secondary Objective:* To assess the effect of teriflunomide in comparison to placebo on disease activity/progression measured by brain magnetic resonance imaging (MRI) and on cognitive function.* To evaluate the safety and tolerability of teriflunomide in comparison to placebo.* To evaluate the pharmacokinetics (PK) of teriflunomide.
DOI: 10.5067/modis/mcd43d47.006
title: MCD43D47 MODIS/Terra+Aqua BRDF/Albedo Black Sky Albedo Band6 Daily L3 Global 30ArcSec CMG V006
DOI: 10.25934/pr00011080
title: Study to Investigate the Immune Response to Influenza Vaccine in Patients With Multiple Sclerosis on Teriflunomide Treatment and Using a Population of Patients With Multiple Sclerosis as a Reference

description: Primary Objective:Assess the antibody response to influenza vaccine in patients with relapsing form of multiple sclerosis (RMS) treated with teriflunomide compared to a reference population.Secondary Objectives:* Assess the effect of teriflunomide on immunoglobulin levels;* Assess the safety of influenza vaccination in patients with RMS treated with teriflunomide.The reference population was defined as multiple sclerosis (MS) patients with a stable treatment with interferon-β-1. Antibody response was measured using hemagglutination inhibition assay (HIA) and the hemagglutinin antigens representing the stains of H3N2, H1N1, and B as present in the influenza vaccine used.
DOI: 10.25934/pr00011081
title: A Randomized, Multinational, Double-Blind, Placebo-Controlled, Parallel-Group Design Pilot Study to Estimate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamic Effects of Teriflunomide for 24 Weeks When Added to Treatment With Interferon-beta in Subjects With Multiple Sclerosis.

description: The primary objective was to estimate the tolerability and safety of 2 doses of teriflunomide administered once daily for 24 weeks, compared with placebo, in patients with multiple sclerosis \[MS\] with relapses who were on a stable dose of interferon-β \[IFN-β\].Secondary objectives were:* to estimate the effects of the 2 doses of teriflunomide, compared to placebo, in combination with a stable dose of IFN-β on Magnetic Resonance Imaging \[MRI\] parameters, relapse rate and patient-reported fatigue;* to perform pharmacokinetic analyses of the 2 doses of teriflunomide in combination with a stable dose of IFN-β.
DOI: 10.25934/pr00011082
title: A Randomized, Multinational, Double-blind, Placebo-controlled, Parallel-group Design Pilot Study to Estimate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamic Effects of Teriflunomide for 24 Weeks When Added to Treatment With Glatiramer Acetate in Subjects With Multiple Sclerosis

description: The primary objective was to estimate the tolerability and safety of 2 doses of Teriflunomide administered once daily for 24 weeks, compared to placebo, in patients with multiple sclerosis \[MS\] with relapses who were on a stable dose of Glatiramer Acetate \[GA\].The secondary objectives were:* to estimate the effect of the 2 doses of Teriflunomide, compared to placebo, in combination with a stable dose of GA on Magnetic Resonance Imaging \[MRI\] parameters, relapse rate and patient-reported fatigue;* to perform pharmacokinetic analyses of the 2 doses of teriflunomide in combination with a stable dose of GA.
DOI: 10.5067/modis/mcd43d48.006
title: MCD43D48 MODIS/Terra+Aqua BRDF/Albedo Black Sky Albedo Band7 Daily L3 Global 30ArcSec CMG V006
DOI: 10.25934/pr00011083
title: A Phase II Study of the Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses

description: The primary objective of this study was to determine the safety and efficacy of teriflunomide in multiple sclerosis (MS) with relapses.Secondary objectives were:* To determine the effect of teriflunomide on additional magnetic resonance imaging (MRI) variables as well as clinical and quality of life measures.* To investigate the pharmacokinetic and pharmacodynamic relationships.
DOI: 10.25934/pr00011084
title: Long-term Extension of the Multinational, Double-blind, Placebo Controlled Studies PDY6045 and PDY6046 to Document the Safety of Teriflunomide When Added to Treatment With Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis With Relapses

description: The primary objective was to evaluate the long-term safety and tolerability of teriflunomide when added to treatment with interferon-β \[IFN-β\] or glatiramer Acetate \[GA\] in patients with multiple sclerosis \[MS\] with relapses.Secondary objectives were to evaluate the long-term effect on relapse rate, disability progression and Magnetic Resonance Imaging \[MRI\] parameters.This study is the extension study of the PDY6045 (NCT00489489) and PDY6046 (NCT00475865) studies. Participants who successfully completed the initial study were offered to continue their treatment (same compound, same dose) for 24 additional weeks.
DOI: 10.5067/modis/mcd43d49.006
title: MCD43D49 MODIS/Terra+Aqua BRDF/Albedo Black Sky Albedo VIS Daily L3 Global 30ArcSec CMG V006
DOI: 10.25934/pr00011085
title: Extension of Protocol HMR1726D/2001, A Phase II Study of the Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses

description: The primary objective is to assess the long-term safety of teriflunomide in multiple sclerosis subjects. The secondary objective is to assess the long-term efficacy.
DOI: 10.25934/pr00011070
title: A Phase III, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Atezolizumab (Anti-PD-L1 Antibody) as Adjuvant Therapy in Patients With Renal Cell Carcinoma at High Risk of Developing Metastasis Following Nephrectomy

description: This is a Phase III, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of atezolizumab versus placebo in participants with RCC who are at high risk of disease recurrence following nephrectomy.
DOI: 10.5067/modis/mcd43d50.006
title: MCD43D50 MODIS/Terra+Aqua BRDF/Albedo Black Sky Albedo NIR Daily L3 Global 30ArcSec CMG V006
DOI: 10.25934/pr00011093
title: A Phase 3, Multicenter, Open-Label, Uncontrolled Study to Evaluate the Efficacy and Safety of Cx601 in the Treatment of Complex Perianal Fistulas in Adult Patients With Crohn's Disease

description: The purpose of this study is to evaluate the efficacy of darvadstrocel for the treatment of complex perianal fistulas in adult participants with Crohn's disease over 24 weeks.
DOI: 10.5067/modis/mcd43d51.006
title: MCD43D51 MODIS/Terra+Aqua BRDF/Albedo Black Sky Albedo Shortwave Daily L3 Global 30ArcSec CMG V006
DOI: 10.25934/pr00011094
title: A Phase-III, Randomized, Double-blind, Parallel-group, Placebo-controlled, International, Multicentre Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Patients With Crohn's Disease Over a Period of 24 Weeks and a Follow-up Period up to 52 Weeks

description: The purpose of this study is to evaluate the combined remission of complex perianal fistulas, defined as the clinical assessment at Week 24 of closure of all treated external openings that were draining at baseline despite gentle finger compression, and absence of collections greater than (\>) 2 centimeter (cm) (in at least 2 dimensions) confirmed by blinded central magnetic resonance imaging (MRI) assessment at Week 24.
DOI: 10.25934/pr00011095
title: A Follow-up of a Phase 3 Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel in the Treatment of Complex Perianal Fistula in Subjects With Crohn's Disease Who Have Participated in ADMIRE II Study

description: The main aim is to follow-up on long term side effect and symptom improvement of Darvadstrocel in the treatment of complex perianal fistula in adults. Participants will not receive any drug in this study.
DOI: 10.5067/modis/mcd43d52.006
title: MCD43D52 MODIS/Terra+Aqua BRDF/Albedo White Sky Albedo Band1 Daily L3 Global 30ArcSec CMG V006
DOI: 10.25934/pr00011096
title: Multicenter Phase I/IIa Study to Assess the Safety and Efficacy of Expanded Allogenic Adipose-derived Stem Cells (eASCs) (Cx601), for Treatment of Complex Perianal Fistulas in Perianal Crohn's Disease.

description: The purpose of this study is to asses the safety and efficacy of adipose-derived adult stem cells from healthy donnors for treatment of complex perianal fistulas in Crohn's disease.
DOI: 10.25934/pr00011097
title: A Phase III, Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicentre Study to Assess Efficacy and Safety of Expanded Allogeneic Adipose-derived Stem Cells (eASCs) for the Treatment of Perianal Fistulising Crohn's Disease Over a Period of 24 Weeks and an Extended Follow-up Period up to 104 Weeks.

description: The current multicentre phase III study is proposed to confirm in an add-on therapy design compared to a placebo-control group, the efficacy of adipose-derived stem cells (eASCs) from healthy donors for the treatment of complex anal fistulas in patients with Crohn's disease over a 24-week period and an extended follow-up period up to 104 weeks.
DOI: 10.5067/modis/mcd43d53.006
title: MCD43D53 MODIS/Terra+Aqua BRDF/Albedo White Sky Albedo Band2 Daily L3 Global 30ArcSec CMG V006