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18 Studies found for: Recruiting Studies | biogen [Lead]

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NCT04089514

Recruiting
New

A Real-world Study of Imraldi® Use

Arthritis, Rheumatoid (RA)
Axial Spondyloarthritis (axSpA)
Arthritis, Psoriatic (PsA)
(and 2 more...)

Drug: Adalimumab

Observational

Biogen
Biogen

Industry

Observational Model: Cohort
Time Perspective: Prospective

Candidate Predictors of Persistence on Adalimumab
Number of Participants by Baseline Clinical Characteristic Categories
Number of Participants by Utilization of Adalimumab Categories
(and 6 more...)

1400

All

18 Years and older (Adult, Older Adult)

NCT04089514

EUR-BIO-18-11391

PROPER

June 30, 2019

June 30, 2021

September 13, 2019

Research Site
Bath, United Kingdom

NCT03976349

Recruiting

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB094 in Adults With Parkinson's Disease

Parkinson's Disease

Drug: BIIB094
Drug: Placebo

Interventional

Phase 1

Biogen
Ionis Pharmaceuticals, Inc.
Biogen

Industry

Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Serum Concentrations of BIIB094
Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUCinf) of BIIB094
(and 4 more...)

All

35 Years to 80 Years (Adult, Older Adult)

NCT03976349

254PD101
2018-002995-42

August 12, 2019

January 8, 2022

June 6, 2019

September 13, 2019

Quest Research Institute
Farmington Hills, Michigan, United States
Alliance for Multispecialty Research NOCCR/VRG
Knoxville, Tennessee, United States
Inland Northwest Research
Spokane, Washington, United States

NCT03958877

Recruiting

A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon Beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis

Multiple Sclerosis, Relapsing-Remitting

Drug: BIIB017 (peginterferon beta-1a)
Drug: Interferon beta type 1a

Interventional

Phase 3

Biogen
Biogen

Industry

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Part 1: Annualized Relapse Rate (ARR) at Week 96
Part 2: Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Study Treatment Discontinuation
Part 1: ARR at Week 48
(and 39 more...)

142

All

10 Years to 18 Years (Child, Adult)

NCT03958877

105MS306
2018-003008-38

October 3, 2019

March 31, 2023

May 22, 2019

September 24, 2019

Research Site
Chapel Hill, North Carolina, United States
Research Site
Norfolk, Virginia, United States
Research Site
Sofia, Bulgaria
(and 5 more...)

NCT03945279

Recruiting

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB100 Administered Orally to Adults With Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis

Drug: BIIB100
Drug: Placebo

Interventional

Phase 1

Biogen
Biogen

Industry

Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Area Under the Concentration-Time Curve From Time 0 to Time of the Last Measurable Concentration (AUClast) of BIIB100
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of BIIB100
(and 5 more...)

All

18 Years and older (Adult, Older Adult)

NCT03945279

261AS101

May 30, 2019

December 31, 2020

May 10, 2019

September 13, 2019

Barrow Neurological Institute
Phoenix, Arizona, United States
Research Site
Loma Linda, California, United States
University of California San Diego Medical Center
San Diego, California, United States
(and 6 more...)

NCT03943056

Recruiting

A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of BIIB091, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Healthy Adult Participants

Healthy Volunteer

Drug: BIIB091
Drug: Placebo

Interventional

Phase 1

Biogen
Biogen

Industry

Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Area Under the Curve from Time 0 to the Time of the Last Measurable Concentration (AUClast)
Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf)
(and 11 more...)

All

18 Years to 55 Years (Adult)

NCT03943056

257HV101

May 13, 2019

December 24, 2019

May 9, 2019

July 31, 2019

Research Site
Dallas, Texas, United States

NCT03870763

Recruiting

Study to Evaluate the Efficacy and Safety of Dimethyl Fumarate (Tecfidera) and Peginterferon Beta-1a (Plegridy) for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants

Multiple Sclerosis, Relapsing-Remitting

Drug: Dimethyl Fumarate
Drug: Peginterferon Beta-1a
Drug: Placebo

Interventional

Phase 3

Biogen
Biogen

Industry

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Time to First Relapse
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of New or Newly Enlarging T2 Hyperintense Lesions on Brain Magnetic Resonance Imaging (MRI) Scans
(and 2 more...)

340

All

10 Years to 17 Years (Child)

NCT03870763

800MS301
2018‐000516‐22

March 19, 2019

February 28, 2020

March 12, 2019

September 19, 2019

Research Site
Raleigh, North Carolina, United States
Research Site
Tallinn, Estonia
Research Site
Budapest, Hungary
(and 3 more...)

NCT03745820

Recruiting

A Study to Evaluate the Safety and Efficacy of BIIB104 in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS)

Cognitive Impairment Associated With Schizophrenia
Schizophrenia

Drug: BIIB104
Other: Placebo

Interventional

Phase 2

Biogen
Biogen

Industry

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Change from Baseline in MATRICS Consensus Cognitive Battery (MCCB) Working Memory Domain Score to Week 12
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Change from Baseline in University of California, San Diego Performance Based Skills Assessment-Brief International Version (UPSA-Bi) Assessment to Week 12
(and 5 more...)

219

All

18 Years to 50 Years (Adult)

NCT03745820

263CS201
2018-003825-27

TALLY

November 15, 2018

April 6, 2020

April 20, 2020

November 19, 2018

August 30, 2019

Research Site
Little Rock, Arkansas, United States
Research Site
Culver City, California, United States
Research site
Garden Grove, California, United States
(and 23 more...)

NCT03716570

Recruiting

A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Japanese Participants With Parkinson's Disease

Parkinson's Disease

Drug: BIIB054
Drug: Placebo

Interventional

Phase 1

Biogen
Biogen

Industry

Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of BIIB054
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of BIIB054
(and 8 more...)

All

40 Years to 80 Years (Adult, Older Adult)

NCT03716570

228PD103

March 12, 2019

August 13, 2021

October 23, 2018

September 9, 2019

Research Site
Toon-shi, Ehime-Ken, Japan
Research Site
Asahikawa-shi, Hokkaido, Japan
Research Site
Kyoto-shi, Kyoto-Fu, Japan
(and 6 more...)

NCT03662919

Recruiting

One-year Persistence to Treatment of Participants Receiving Flixabi: a French Cohort Study

Arthritis, Rheumatoid
Spondylitis, Ankylosing
Arthritis, Psoriatic
(and 2 more...)

Drug: Infliximab

Observational

Biogen
Biogen

Industry

Observational Model: Cohort
Time Perspective: Prospective

Percentage of Participants who are Still Treated by Flixabi at 12 Months

1500

All

6 Years and older (Child, Adult, Older Adult)

NCT03662919

FRA-FLX-17-11226
2017-A03220-53

PERFUSE

July 2, 2018

July 1, 2021

September 10, 2018

Research Site
Bobigny, France
Research Site
Clichy, France
Research Site
Creteil, France
(and 7 more...)

NCT03339336

Recruiting

Efficacy and Safety Study of BIIB074 in Participants With Small Fibre Neuropathy

Small Fibre Neuropathy
Diabetes Mellitus

Drug: BIIB074
Drug: Placebo

Interventional

Phase 2

Biogen
Biogen

Industry

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Change from Baseline in Weekly Mean Average Daily Pain (ADP) Score
Change from Randomization in Weekly Mean ADP Score
Change from Baseline in Weekly Mean Worst Daily Pain (WDP) Score
(and 10 more...)

186

All

18 Years and older (Adult, Older Adult)

NCT03339336

802NP206
2017-000991-27

April 16, 2018

August 27, 2020

November 13, 2017

August 20, 2019

Research Site
Byala, Bulgaria
UMHAT 'Dr Georgi Stranski' EAD
Pleven, Bulgaria
Research Site
Plovdiv, Bulgaria
(and 76 more...)

NCT03283371

Recruiting

Phase 2 Efficacy, Safety, and Tolerability Study of Natalizumab in Focal Epilepsy

Epilepsy, Focal Seizures, Partial Seizures

Drug: Natalizumab
Other: Placebo

Interventional

Phase 2

Biogen
Biogen

Industry

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Change from Baseline in Log-Transformed Seizure Frequency during Weeks 8 to 24 of Treatment
Percentage of Responders
Percentage of Participants Free from Seizures
(and 2 more...)

All

18 Years to 75 Years (Adult, Older Adult)

NCT03283371

101EP201
2017-001995-45

OPUS

March 20, 2018

January 16, 2020

December 16, 2020

September 14, 2017

August 26, 2019

Research Site
Birmingham, Alabama, United States
Research Site
Phoenix, Arizona, United States
Research Site
Phoenix, Arizona, United States
(and 44 more...)

NCT03177083

Recruiting

Evaluate Safety/Tolerability in Portuguese Participants With RRMS Transitioning From Current Therapy

Relapsing Remitting Multiple Sclerosis

Drug: peginterferon beta-1a
Drug: interferon beta-1a
Drug: interferon beta-1b

Interventional

Phase 4

Biogen
Biogen

Industry

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Combined counts of Adverse Events (AEs) of flu-like symptoms (FLS)
Combined counts of AEs of injection site reactions (ISRs)
Combined counts of AEs of ISR pain (ISRP)
(and 40 more...)

140

All

18 Years to 65 Years (Adult, Older Adult)

NCT03177083

PRT-PEG-15-10880
2016-000434-21

PLENO

January 30, 2017

March 30, 2020

June 6, 2017

September 13, 2018

Hospital Fernando Fonseca
Amadora, Portugal
Hospital de Braga
Braga, Portugal
Hospital Evora
Evora, Portugal
(and 10 more...)

NCT03056729

Recruiting

Single-Ascending-Dose Study of BIIB076 in Healthy Volunteers and Participants With Alzheimer's Disease

Alzheimer's Disease
Healthy Volunteer

Drug: BIIB076
Drug: Placebo

Interventional

Phase 1

Biogen
Biogen

Industry

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment

Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
BIIB076 serum pharmacokinetics (PK) concentration levels
PK parameter of BIIB076: Area under the concentration-time curve from time zero to infinity (AUCinf)
(and 7 more...)

All

50 Years to 80 Years (Adult, Older Adult)

NCT03056729

243HV101

February 17, 2017

February 14, 2020

February 17, 2017

September 6, 2019

MD Clinical
Hallandale Beach, Florida, United States
Bioclinica Research
Orlando, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
(and 6 more...)

NCT02996084

Recruiting

MS PATHS Normative Sub-Study

Healthy Volunteer

Observational

Biogen
Biogen

Industry

Observational Model: Cohort
Time Perspective: Prospective

Brain volume
Brain volume change
Development of models to calibrate brain volume measurements between centers, if necessary

200

All

21 Years to 60 Years (Adult)

NCT02996084

888MS005

December 12, 2017

December 15, 2022

December 19, 2016

August 8, 2019

Johns Hopkins University
Baltimore, Maryland, United States
Washington University
Saint Louis, Missouri, United States
University of Rochester Medical Center
Rochester, New York, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States

NCT02864953

Recruiting

Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema Following Large Hemispheric Infarction

Brain Edema
Stroke, Acute

Drug: BIIB093
Drug: Placebo

Interventional

Phase 3

Biogen
Biogen

Industry

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Proportion of Participants with Improvement in Functional Outcome at Day 90 Assessed via the Modified Rankin Scale (mRS)
Time to All-Cause Death
Proportion of Participants Who Achieved mRS 0-4 at Day 90
(and 2 more...)

680

All

18 Years to 85 Years (Adult, Older Adult)

NCT02864953

252LH301
RPI 301
2017-004854-41

CHARM

August 29, 2018

March 31, 2021

December 30, 2021

August 12, 2016

March 4, 2019

Research Site
Phoenix, Arizona, United States
Research Site
Phoenix, Arizona, United States
Research Site
Palo Alto, California, United States
(and 189 more...)

NCT02623699

Recruiting

An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BIIB067 in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS)

Amyotrophic Lateral Sclerosis

Drug: BIIB067
Other: Placebo

Interventional

Phase 3

Biogen
Ionis Pharmaceuticals, Inc.
Biogen

Industry

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
Number of Participants With Clinically Significant Vital Sign Abnormalities
(and 24 more...)

144

All

18 Years and older (Adult, Older Adult)

NCT02623699

233AS101
2015-004098-33

January 20, 2016

May 29, 2020

December 8, 2015

September 5, 2019

Barrow Neurological Institute
Phoenix, Arizona, United States
University of California San Diego Medical Center
La Jolla, California, United States
California Pacific Medical Center
San Francisco, California, United States
(and 18 more...)

NCT02047097

Recruiting

Dimethyl Fumarate (DMF) Observational Study

Multiple Sclerosis

Drug: dimethyl fumarate

Observational

Biogen
Biogen

Industry

Observational Model: Cohort
Time Perspective: Prospective

The number of participants that experience Adverse Events (AEs) that lead to discontinuation of dimethyl fumarate (DMF)
The number of participants that experience Serious Adverse Events (SAEs)
Duration of dimethyl fumarate (DMF) use
(and 11 more...)

5600

All

18 Years and older (Adult, Older Adult)

NCT02047097

109MS401

ESTEEM

November 30, 2013

February 28, 2024

January 28, 2014

July 11, 2019

Research Site
Birmingham, Alabama, United States
Research Site
Gilbert, Arizona, United States
Research Site
Phoenix, Arizona, United States
(and 391 more...)

NCT01911767

Recruiting

Biogen Multiple Sclerosis Pregnancy Exposure Registry

Multiple Sclerosis
Exposure During Pregnancy

Drug: Dimethyl fumarate
Drug: Peginterferon beta-1a

Observational

Biogen
Biogen

Industry

Observational Model: Cohort
Time Perspective: Prospective

Pregnancy Loss
Live Birth

1125

Female

Child, Adult, Older Adult

NCT01911767

109MS402

October 30, 2013

May 31, 2028

July 30, 2013

March 21, 2019

Research Site
Cambridge, Massachusetts, United States
Research Site
Box Hill, Victoria, Australia
Research Site
Bochum, Nordrhein Wesfalen, Germany
(and 8 more...)

† Study has passed its completion date and status has not been verified in more than two years.

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