Arthritis, RheumatoidLODOTRANCT01075711
Determine the Improvement in Activity Status/Quality of Life (QoL) of Patients With Rheumatoid Arthritis (RA) During Treatment With Lodotra (Prednisone)
An observational study of Arthritis, Rheumatoid, run by Merck KGaA, Darmstadt, Germany at 1 site in Germany.
Trial summary
Rheumatoid arthritis is the most common rheumatic disease with symptomatic morning stiffness which entails a quite essential restriction in the everyday life and in the life quality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Prednisone
- How many people
- 2,728 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2009to Nov 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with RA who are treated with Tempus tablet and subjects with re-diagnosed RA are also included in the study, if the RA is treated with glucocorticoides.
Who may be able to join
- Subjects who correspond to the permitted indication of the drug of Lodotra
- Subjects from age of 18 years with diagnosed, active RA with associated symptoms such as morning stiffness of the joints, which is either already being treated with low dose of glucocorticoids or will be treated again with glucocorticoid therapy
Who cannot join
- - Subjects with contraindications are excluded from the participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-interventional Study for Determining the Improvement in the Activity Status / Life Quality of Patients With Rheumatoid Arthritis Being Treated With the Tempus Tablet
Rheumatoid arthritis is the most common rheumatic disease with symptomatic morning stiffness which entails a quite essential restriction in the everyday life and in the life quality. This observational, uncontrolled, multicentric study is aimed to assess the improvement in the activity status or QoL of subjects with RA being treated with the Tempus tablet.
Read the detailed description
Rheumatoid arthritis is characterised with a sudden onset , with pains in the little finger or toe joints, progressively affecting various joints and symptomatic morning stiffness. For subjects with RA, morning stiffness entails a quite essential restriction in the everyday life and in the life quality. This observational, uncontrolled, multicentric study is aimed to assess the improvement in the activity status or QoL of subjects with RA being treated with the Tempus tablet. A total of 8,000 subjects with diagnosed, active RA will be included in the study The study will apply to 2 target groups: general physicians, practicing doctors and interns (in-house doctors) with an observation period of 3 months; and specialists (rheumatologist) with an observation period of 9 months. Three subjects are expected per in-house doctor and 10 subjects per rheumatologist.
OBJECTIVES
Primary Objective:
- To examine, to what extent the subject will be directly benefited with the decrease in the morning arthritis symptom in the sense of an improvement in the life quality and the activity status
- The activity status will be assessed in 3 different areas: occupational activities, tasks in the household and leisure activities
- The life quality is assessed on the basis of the HAQ-DI
Secondary Objectives:
- To record side effects of Tempus tablet when used under everyday conditions
- To collect socioeconomic data such as e.g. aids or applications
- Conditions
- Arthritis, Rheumatoid
- Being tested
- Prednisone
- Keywords
- Arthritis, Rheumatoid, Prednisone
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
Also called Lodotra
According to SPC
| Study group | Role | What they receive |
|---|---|---|
| NIS in-house doctors | This group will be assigned to general physicians, practicing doctors and interns (in-house doctors) with an observation period of 3 months. Three subjects are expected per in-house doctor therefore altogether, 1000 in-house doctors will be obtained or appointed for the observation study. Receives: Drug: Prednisone | |
| NIS specialists | This group will be assigned to specialists (rheumatologist) with an observation period of 9 months. Ten subjects per rheumatologist are expected therefore altogether, 500 rheumatologists will be obtained or appointed for the observation study. Receives: Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the QAS (Questionnaire on Activity Status)
Measured: Beginning of the examination (gross-root survey) and after 3 months (follow-up)
Secondary outcomes (6)
QAS comparison after 9 months
Measured: Beginning until after 9 months
Performance by visual analog scale (VAS)
Measured: Beginning until after 9 months
Concurrent medication
Measured: Beginning until after 9 months
Health Assessment Questionnaire Disability Index (HAQ-DI) (NIS specialists)
Measured: Beginning until after 9 months
Laboratory results (c reactive protein [CRP], BSG), X-rays (if available)
Measured: Beginning until after 9 months
Side-effects and undesirable events
Measured: Beginning until after 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2010 (estimated)
- Study startApr 2009
- Primary completionSep 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,728 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Serono GmbH, Germany
- Responsible party
- Sponsor
- Investigators
- Dr. Boris Pfeiffer, M.Sc., Study director, Merck Serono GmbH, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01075711
- Sponsor's protocol ID
- 062215-500
- Acronym
- LODOTRA
- Status last verified
- Feb 2014
- First submitted
- 24 Feb 2010
- Last updated
- 19 Feb 2014
- Results posted
- No
Publications
Pfeiffer BM, Krenzer S, Dockhorn R, Schwenke R, Schwenke H, Waehrisch J, Kraus E. Impact of modified-release prednisone on functional ability in patients with rheumatoid arthritis. Rheumatol Int. 2013 Jun;33(6):1447-54. doi: 10.1007/s00296-012-2583-1. Epub 2012 Nov 21.
PubMed 23179262
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study for Determining the Improvement in the Activity Status / Life Quality of Patients With Rheumatoid Arthritis Being Treated With the Tempus Tablet
- ClinicalTrials.gov ID
- NCT01075711
- Acronym / sponsor ID
- LODOTRA / 062215-500
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Arthritis, Rheumatoid, Prednisone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,728 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck Serono GmbH, Germany
- Study start
- Apr 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 25 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rheumatoid arthritis is the most common rheumatic disease with symptomatic morning stiffness which entails a quite essential restriction in the everyday life and in the life quality. This observational, uncontrolled, multicentric study is aimed to assess the improvement in the activity status or QoL of subjects with RA being treated with the Tempus tablet.
Detailed description
Rheumatoid arthritis is characterised with a sudden onset , with pains in the little finger or toe joints, progressively affecting various joints and symptomatic morning stiffness. For subjects with RA, morning stiffness entails a quite essential restriction in the everyday life and in the life quality. This observational, uncontrolled, multicentric study is aimed to assess the improvement in the activity status or QoL of subjects with RA being treated with the Tempus tablet. A total of 8,000 subjects with diagnosed, active RA will be included in the study The study will apply to 2 target groups: general physicians, practicing doctors and interns (in-house doctors) with an observation period of 3 months; and specialists (rheumatologist) with an observation period of 9 months. Three subjects are expected per in-house doctor and 10 subjects per rheumatologist.
OBJECTIVES
Primary Objective:
- To examine, to what extent the subject will be directly benefited with the decrease in the morning arthritis symptom in the sense of an improvement in the life quality and the activity status
- The activity status will be assessed in 3 different areas: occupational activities, tasks in the household and leisure activities
- The life quality is assessed on the basis of the HAQ-DI
Secondary Objectives:
- To record side effects of Tempus tablet when used under everyday conditions
- To collect socioeconomic data such as e.g. aids or applications
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIS in-house doctors | – | Drug: PrednisoneThis group will be assigned to general physicians, practicing doctors and interns (in-house doctors) with an observation period of 3 months. Three subjects are expected per in-house doctor therefore altogether, 1000 in-house doctors will be obtained or appointed for the observation study. |
| NIS specialists | – | Drug: PrednisoneThis group will be assigned to specialists (rheumatologist) with an observation period of 9 months. Ten subjects per rheumatologist are expected therefore altogether, 500 rheumatologists will be obtained or appointed for the observation study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with RA who are treated with Tempus tablet and subjects with re-diagnosed RA are also included in the study, if the RA is treated with glucocorticoides.
Key inclusion criteria (2 listed)
- Subjects who correspond to the permitted indication of the drug of Lodotra
- Subjects from age of 18 years with diagnosed, active RA with associated symptoms such as morning stiffness of the joints, which is either already being treated with low dose of glucocorticoids or will be treated again with glucocorticoid therapy
Key exclusion criteria (1 listed)
- - Subjects with contraindications are excluded from the participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrednisoneAlso: LodotraAccording to SPC | Drug | NIS in-house doctors, NIS specialists |
Primary outcome
Change in the QAS (Questionnaire on Activity Status)
Time frame: Beginning of the examination (gross-root survey) and after 3 months (follow-up)
6 secondary outcomes
QAS comparison after 9 months
Time frame: Beginning until after 9 months
Performance by visual analog scale (VAS)
Time frame: Beginning until after 9 months
Concurrent medication
Time frame: Beginning until after 9 months
Health Assessment Questionnaire Disability Index (HAQ-DI) (NIS specialists)
Time frame: Beginning until after 9 months
Laboratory results (c reactive protein [CRP], BSG), X-rays (if available)
Time frame: Beginning until after 9 months
Side-effects and undesirable events
Time frame: Beginning until after 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2014.
- Results publication: PubMed 23179262Pfeiffer BM, Krenzer S, Dockhorn R, Schwenke R, Schwenke H, Waehrisch J, Kraus E. Impact of modified-release prednisone on functional ability in patients with rheumatoid arthritis. Rheumatol Int. 2013 Jun;33(6):1447-54. doi: 10.1007/s00296-012-2583-1. Epub 2012 Nov 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Boris Pfeiffer, M.Sc. study director
Merck Serono GmbH, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Rheumatoid, run by Merck KGaA, Darmstadt, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the QAS (Questionnaire on Activity Status) (time frame: Beginning of the examination (gross-root survey) and after 3 months (follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01075711, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2014.