MedDataX Logo

Benepali® PEN Patient Satisfaction Survey

NCT ID: NCT03327454

Last Updated: 2018-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-10

Study Completion Date

2018-06-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The main aim of this study is to ascertain general satisfaction among participants with rheumatic diseases with day-to-day use of the Benepali® prefilled pen by means of a standardised participant questionnaire. In addition, it is to be investigated whether differences exist in general participant satisfaction between participant groups who have undergone various prior treatment and/or have previous experience with application systems (participants new to the use of biologics, participants changing over from a prefilled injection or changing over from another pre-filled pen) and between participants of the various indication groups. Furthermore, the participants are to evaluate various aspects of using the Benepali® pre-filled pen based on their personal experience, such as e.g. handling, user-friendliness and features of the Benepali® pre-filled pen, as well as the effectiveness of the training on injection with the Benepali® pre-filled pen, based on participant satisfaction with the training received with the training pen and the evaluation of the training material received.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Long-Term Safety Follow-Up Of Subjects Previously Enrolled In Rheumatoid Arthritis Studies Of CP-690,550

NCT00414661

Arthritis, Rheumatoid
COMPLETED

A 6-month Randomised, Double-blind, Open Arm Comparator, Phase IIb, With AZD9056, in Patients With Rheumatoid Arthritis (RA)

NCT00520572

Rheumatoid Arthritis
COMPLETED PHASE2

An Observational Study to Describe in Routine Clinical Practice the Treatment Patterns of Usage of Biological DMARDs in RA Patients.

NCT02590562

Rheumatoid Arthritis
COMPLETED

Assessment of the Clinical and Medico-economic Impact of SinnoTest® in Patients With Rheumatoid Arthritis

NCT04117165

Arthritis, Rheumatoid Biological Therapy
WITHDRAWN NA

Pentoxifylline as Anti-Inflammatory in Patients With Rheumatoid Arthritis

NCT06998628

Rheumatoid Arthritis
RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rheumatoid Arthritis Spondyloarthropathies

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Benepali

Treatment of participants with the Benepali pre-filled pen takes place in accordance with the prescribing information and standard medical practice.

Benepali

Intervention Type BIOLOGICAL

Administered as specified in the treatment arm.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Benepali

Administered as specified in the treatment arm.

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Etanercept

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosis of moderate to severe active rheumatoid arthritis, severe active and progressive rheumatoid arthritis, active and progressive psoriatic arthritis, severe active ankylosing spondylitis, or severe non-radiographic axial spondyloarthritis
* Current treatment with the Benepali® pre-filled pen in accordance with prescribing information for at least 3 months beforehand
* The patient has signed a declaration of consent to take part in the study

Exclusion Criteria

* Patients who are receiving Benepali® for the treatment of moderate to severe plaque psoriasis
* Patients who exhibit contraindications in accordance with the prescribing information for Benepali® and therefore treatment with Benepali ® is not indicated
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Altenholz, , Germany

Site Status

Research Site

Bad Neuenahr-Ahrweiler, , Germany

Site Status

Research Site

Berlin, , Germany

Site Status

Research Site

Berlin, , Germany

Site Status

Research Site

Berlin, , Germany

Site Status

Research Site

Berlin, , Germany

Site Status

Research Site

Berlin, , Germany

Site Status

Research Site

Berlin, , Germany

Site Status

Research Site

Braunschweig, , Germany

Site Status

Research Site

Coburg, , Germany

Site Status

Research Site

Cologne, , Germany

Site Status

Research Site

Dresden, , Germany

Site Status

Research Site

Düsseldorf, , Germany

Site Status

Research Site

Ehringshausen, , Germany

Site Status

Research Site

Erfurt, , Germany

Site Status

Research Site

Essen, , Germany

Site Status

Research Site

Giessen, , Germany

Site Status

Research Site

Göpping, , Germany

Site Status

Research Site

Halle, , Germany

Site Status

Research Site

Hamburg, , Germany

Site Status

Research Site

Homburg, , Germany

Site Status

Research Site

Jülich, , Germany

Site Status

Research Site

Kronach, , Germany

Site Status

Research Site

Leipzig, , Germany

Site Status

Research Site

Leipzig, , Germany

Site Status

Research Site

Ludwigshafen, , Germany

Site Status

Research Site

Magdeburg, , Germany

Site Status

Research Site

Mansfeld, , Germany

Site Status

Research Site

Mittelherwigsdorf, , Germany

Site Status

Research Site

München, , Germany

Site Status

Research Site

Neuss, , Germany

Site Status

Research Site

Norderstedt, , Germany

Site Status

Research Site

Nuremberg, , Germany

Site Status

Research Site

Offenberg, , Germany

Site Status

Research Site

Saarbrücken, , Germany

Site Status

Research Site

Seesen, , Germany

Site Status

Research Site

Tübingen, , Germany

Site Status

Research Site

Ulm, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GER-BNP-16-11103

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Etanercept SFP in RA Patients
NCT00413452 COMPLETED PHASE3
Biomarker Signature and Musculoskeletal Ultrasound Profile in Rheumatoid Arthritis Patients
NCT02476084 COMPLETED
Study Evaluating the Safety and Efficacy of Etanercept in Patients With Psoriatic Arthritis Treated by Rheumatologists
NCT00293722 COMPLETED
Study Comparing Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept
NCT00459706 COMPLETED PHASE3
A Study To Evaluate The Mechanism Of Action Of CP-690,550 In Patients With Rheumatoid Arthritis
NCT00976599 COMPLETED PHASE2
A Study of the Effects of Oral Prednisone in Patients With Rheumatoid Arthritis (MK0000-088)
NCT00746512 COMPLETED PHASE1
Serum Biomarkers Analysis in Patients With AR Treated With Anti-TMF
NCT02804204 UNKNOWN
Study To Evaluate The Response To Enbrel And The Impact Of Rheumatoid Factor(RF) And Anti-Cyclic Citrullinated Peptide(Anti-CCP) In Rheumatoid Arthritis(RA) Patients
NCT04428424 COMPLETED
Study Evaluating Enbrel in Patients With Rheumatoid Arthritis
NCT00245934 COMPLETED
Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response
NCT03414502 RECRUITING PHASE3
Preference of Rheumatoid Arthritis (RA) Patients of Enbrel® (Etanercept) Auto-Injector Versus Enbrel® Pre-Filled Syringes
NCT00094341 COMPLETED PHASE4
A Study To Evaluate The Efficacy Of Enbrel (REGISTERED) Etanercept Over A Period Of 12 Months In The Routine Treatment Of Patients With Rheumatoid Arthritis, Axial Spondyloarthritis, Psoriatic Arthritis, Or Plaque Psoriasis.
NCT02486302 COMPLETED
Discontinuation of TNF-alpha Inhibitors in Patients With Spondyloarthritis
NCT00726804 TERMINATED PHASE4
Characterize Patients With Moderately Active Rheumatoid Arthritis (RA)
NCT01557322 COMPLETED
TNFalfa Blocking Treatment of Spondylarthropathies
NCT00133315 COMPLETED PHASE4
The Oxylipin Response as a New PrEdictive Biomarker of Patient Responsiveness to Biotherapy in Rheumatoid Arthritis (OPERA)
NCT05552105 COMPLETED NA
A Study of the Safety and Pharmacokinetics of PRO283698 in Patients With Rheumatoid Arthritis
NCT00888745 COMPLETED PHASE1
Study Comparing Etanercept (ETN) Against a Placebo for Etanercept on a Background Nonsteroidal Anti Inflammatory Drug (NSAIDs) in the Treatment of Early Spondyloarthritis (SpA) Patients Who do Not Have X-ray Structural Changes
NCT01258738 COMPLETED PHASE3
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of ENIA11 in Combination With DMARDs Versus DMARDs Alone in Patients With Rheumatoid Arthritis
NCT01787149 UNKNOWN PHASE3
Prevalence Study of Gastrointestinal Risk Factors in Patients With Osteoarthritis (OA), Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS).
NCT01577563 COMPLETED
MRI Evaluation Assessing Synovitis to Address the Unmet Need for Reliable Endpoints in SLE
NCT03355482 TERMINATED PHASE2
Drug Outcome Survey for Biological Treatments in Rheumatoid Arthritis: an Observational Study (Dose)
NCT00794118 COMPLETED
Evaluation of TNFα Blockers Monotherapy in Early Rheumatoid Arthritis in France
NCT02927535 COMPLETED
Evaluation of Spironolactone Efficacy in Patient with Rheumatoid Arthritis (RA)
NCT05092984 RECRUITING PHASE3
Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis
NCT00913458 COMPLETED PHASE4