An observational study in Multiple Sclerosis, Relapsing-Remitting, sponsored by Biogen. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-25.
Sponsored by Biogen · Observational
Among 78 studies in Multiple Sclerosis, Relapsing-Remitting by Biogen — none open to participants now, 1 under way, 1 of them phase 3. Multiple Sclerosis, Relapsing-Remitting · Biogen.
Among the 78 studies in Multiple Sclerosis, Relapsing-Remitting by Biogen, this one is the 4th largest by enrollment of the 19 observational ones that give a count, is one of 5 that started in 2017, is one of 19 observational ones, and was the 67th registered.
618 studies on the registry are indexed under Multiple Sclerosis, Relapsing-Remitting; 82 are open to participants now.
Browse Multiple Sclerosis, Relapsing-Remitting studies →None of the 78 studies in Multiple Sclerosis, Relapsing-Remitting by Biogen is open now.
Of the 59 Multiple Sclerosis, Relapsing-Remitting studies recruiting now, 11 (19%) set no upper age limit and 42 (71%) stop at 75 or younger; 2 take children under 18; 11 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
78 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 5 started in 2017.
This study's enrollment of 626 is above the median of 120 across 157 observational studies indexed under Multiple Sclerosis, Relapsing-Remitting.
Median enrollment 152 across the 59 interventional studies, 277 across the 19 observational. Of the 72 that completed or were terminated, 31 (43%) have results posted.
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Biogen is the lead sponsor of 511 studies on the registry; 24 are open to participants now.
Of its 100 completed or terminated interventional studies of FDA-regulated products, 50 (50%) have results posted.
1 of the studies in Multiple Sclerosis, Relapsing-Remitting by Biogen that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03958877Phase 3BiogenA Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon Beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis | 2027-05-20 |
Among the 78 studies in Multiple Sclerosis, Relapsing-Remitting by Biogen, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The purpose of this study is to investigate the safety of subcutaneous (SC) interferon beta therapies with regard to frequency of injection site reactions (ISR) and flu-like symptoms (FLS) as reported by the relapsing-remitting multiple sclerosis (RRMS) participants.
Participants with RRMS, who are currently stable on a SC interferon beta treatment for at least three months and maximum four years (switch between SC interferon beta treatments possible) will be enrolled in the study.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with relapsing-remitting multiple sclerosis (RRMS), currently stable on SC interferon beta treatment for three months or longer (switch between SC interferon beta treatments possible).
Drug: SC Peginterferon beta-1a
Participants with relapsing-remitting multiple sclerosis (RRMS), currently stable on SC interferon beta treatment for three months or longer (switch between SC interferon beta treatments possible).
Drug: SC interferon beta-1a
Participants with relapsing-remitting multiple sclerosis (RRMS), currently stable on SC interferon beta treatment for three months or longer (switch between SC interferon beta treatments possible).
Drug: SC interferon beta-1b
All participants will be treated with their current SC interferon beta medication according to the Fachinformation (German equivalent to summary of product characteristics \[SmPC\]).
Also known as: Plegridy
All participants will be treated with their current SC interferon beta medication according to the Fachinformation (German equivalent to summary of product characteristics \[SmPC\]).
Also known as: Rebif
All participants will be treated with their current SC interferon beta medication according to the Fachinformation (German equivalent to summary of product.
Also known as: Betaferon, Extavia
Percentage of Participants with at Least one Injection Site Reaction (ISR) as Reported by the Participants
ISRs include symptoms like redness, pain, heat, swelling, hematoma (bruising), induration (hardness), blistering, itching, burning, a sore or pus.
Time frame: Day 1
Percentage of Participants with at Least one Flu-like Symptoms (FLS) as Reported by the Participants
Flu-like symptoms are specified by fever, chills, aching limbs, headache, sweating, fatigue or weakness.
Time frame: Day 1
Percentage of Participants with at Least one ISR (FLS) as Reported by the Nurse
ISR (FLS) denote events regarding ISR which will be evaluated for FLS simultaneously. ISRs include symptoms like redness, pain, heat, swelling, hematoma (bruising), induration (hardness), blistering, itching, burning, a sore or pus. Flu-like symptoms are specified by fever, chills, aching limbs, headache, sweating, fatigue or weakness.
Time frame: Day 1
Percentage of Participants with at Least one ISR (FLS) as Reported by the Physician
ISR (FLS) denote events regarding ISR which will be evaluated for FLS simultaneously. ISRs include symptoms like redness, pain, heat, swelling, hematoma (bruising), induration (hardness), blistering, itching, burning, a sore or pus. Flu-like symptoms are specified by fever, chills, aching limbs, headache, sweating, fatigue or weakness.
Time frame: Day 1
Percentage of Participants with Types of ISR (FLS) Reported by Participants, Nurses, and Physician
ISR (FLS) denote events regarding ISR which will be evaluated for FLS simultaneously. ISRs include symptoms like redness, pain, heat, swelling, hematoma (bruising), induration (hardness), blistering, itching, burning, a sore or pus. Flu-like symptoms are specified by fever, chills, aching limbs, headache, sweating, fatigue or weakness.
Time frame: Day 1
Duration of ISR (FLS) Reported by Participants, Nurses, and Physician
ISR (FLS) denote events regarding ISR which will be evaluated for FLS simultaneously. ISRs include symptoms like redness, pain, heat, swelling, hematoma (bruising), induration (hardness), blistering, itching, burning, a sore or pus. Flu-like symptoms are specified by fever, chills, aching limbs, headache, sweating, fatigue or weakness.
Time frame: Day 1
Usual Time of Occurrence of ISR (FLS) as Reported by the Participants, Nurses and Physicians
ISR (FLS) denote events regarding ISR which will be evaluated for FLS simultaneously. ISRs include symptoms like redness, pain, heat, swelling, hematoma (bruising), induration (hardness), blistering, itching, burning, a sore or pus. Flu-like symptoms are specified by fever, chills, aching limbs, headache, sweating, fatigue or weakness.
Time frame: Day 1
Interference Score of ISR (FLS) With Participant's Daily Activities
ISR (FLS) denote events regarding ISR which will be evaluated for FLS simultaneously. Interference of ISR (FLS) with participant's daily activities will be assessed by a visual analogue scale ranging from '0' (not at all) to '10' (extremely).
Time frame: Day 1
Number of Participants Taking Treatments/Actions to Relieve the ISR (FLS) Assessed by Participants, Nurses and Physicians
ISR (FLS) denote events regarding ISR which will be evaluated for FLS simultaneously. ISRs include symptoms like redness, pain, heat, swelling, hematoma (bruising), induration (hardness), blistering, itching, burning, a sore or pus. Flu-like symptoms are specified by fever, chills, aching limbs, headache, sweating, fatigue or weakness.
Time frame: Day 1
Percentage of Participants With at Least one Self-administered Treatment/Action Resulting in Disappearance or Relief of ISR/FLS
ISR (FLS) denote events regarding ISR which will be evaluated for FLS simultaneously. ISRs include symptoms like redness, pain, heat, swelling, hematoma (bruising), induration (hardness), blistering, itching, burning, a sore or pus. Flu-like symptoms are specified by fever, chills, aching limbs, headache, sweating, fatigue or weakness.
Time frame: Day 1
Percentage of Participants With Reducing or Increasing Frequency of ISR/FLS Compared to Previous Therapy
ISR (FLS) denote events regarding ISR which will be evaluated for FLS simultaneously. ISRs include symptoms like redness, pain, heat, swelling, hematoma (bruising), induration (hardness), blistering, itching, burning, a sore or pus. Flu-like symptoms are specified by fever, chills, aching limbs, headache, sweating, fatigue or weakness.
Time frame: Day 1
Percentage of Participants With Reducing or Increasing Intensity of ISR/FLS Compared to Previous Therapy
ISR (FLS) denote events regarding ISR which will be evaluated for FLS simultaneously. ISRs include symptoms like redness, pain, heat, swelling, hematoma (bruising), induration (hardness), blistering, itching, burning, a sore or pus. Flu-like symptoms are specified by fever, chills, aching limbs, headache, sweating, fatigue or weakness.
Time frame: Day 1
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2017 to primary completion in Jul 2019, 20 months.
Of 26 industry-sponsored observational studies under Multiple Sclerosis, Relapsing-Remitting, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 55. This study's 20 months is below that.
Counting every sponsor, half of 67 studies reached it within 41 months; a quarter within 23 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Multiple Sclerosis, Relapsing-Remitting →