An observational study in Rheumatoid Arthritis and Spondyloarthropathies, sponsored by Biogen. Completed at 38 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-23.
Sponsored by Biogen · Observational
Among 16 studies in Arthritis, Rheumatoid by Biogen — none open to participants now, none under way, none of them phase 3. Arthritis, Rheumatoid · Biogen.
Among the 16 studies in Arthritis, Rheumatoid by Biogen, this one is one of 2 that started in 2017, is one of 5 observational ones, and was the 14th registered.
3,334 studies on the registry are indexed under Arthritis, Rheumatoid; 444 are open to participants now.
Browse Arthritis, Rheumatoid studies →None of the 16 studies in Arthritis, Rheumatoid by Biogen is open now. The open studies under Arthritis, Rheumatoid, anywhere →
Of the 293 Arthritis, Rheumatoid studies recruiting now, 150 (51%) set no upper age limit and 109 (37%) stop at 75 or younger; 15 take children under 18; 36 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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16 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 500 is above the median of 176 across 1,017 observational studies indexed under Arthritis, Rheumatoid.
Median enrollment 94 across the 10 interventional studies, 585 across the 5 observational. Of the 15 that completed or were terminated, 2 (13%) 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.
None of the studies under way reaches primary completion within a year.
Among the 16 studies in Arthritis, Rheumatoid by Biogen, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Participants who are treated by practitioners in Germany and who are eligible according to the inclusion/exclusion criteria.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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.
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.
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.
Treatment of participants with the Benepali pre-filled pen takes place in accordance with the prescribing information and standard medical practice.
Biological: Benepali
Administered as specified in the treatment arm.
Also known as: Etanercept
Percentage of Participants that are "Very Satisfied (4)" or "Satisfied (3)" with the Benepali Pre-Filled Pen
The Questionnaire is based on a 5-point Likert scale where 0 = very dissatisfied, 1 = dissatisfied, 2 = neither dissatisfied nor satisfied, 3 = satisfied, 4 = very satisfied.
Time frame: Day 1
Percentage of Participants that Answered Questions on Their Personal Experience of Various Aspects of Using the Benepali Pre-Filled Pen with a (3) or (4) on a 5-point Likert Scale.
The questions comprise the areas of handling, user-friendliness and features of the Benepali® pre-filled pen, satisfaction compared with the previous application system and satisfaction with the training on injection with the training pen. 0 = worst rating, 4 = best rating.
Time frame: Day 1
Percentage of Participants that Answered "Yes" in Terms of Satisfaction with Training Materials
The participants evaluated the training materials and answered "yes" or "no" to questions regarding the adequate effectiveness, clarity, and extent of information provided.
Time frame: Day 1
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2017 to primary completion in Jun 2018, 10 months.
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This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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