Clinical trial NCT01075711: Determine the Improvement in Activity Status/Quality of Life (QoL) of Patients With Rheumatoid Arthritis (RA) During Treatment With Lodotra (Prednisone)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid
Keywords: Arthritis, Rheumatoid
Prednisone
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck Serono GmbH, Germany
First posted: 2010-02-25
Enrollment: 2728
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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

  1. The activity status will be assessed in 3 different areas: occupational activities, tasks in the household and leisure activities
  2. 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* - Subjects with contraindications are excluded from the participation

Primary outcomes:
measure: Change in the QAS (Questionnaire on Activity Status)
timeFrame: Beginning of the examination (gross-root survey) and after 3 months (follow-up)
Secondary outcomes:
measure: QAS comparison after 9 months
timeFrame: Beginning until after 9 months
measure: Performance by visual analog scale (VAS)
timeFrame: Beginning until after 9 months
measure: Concurrent medication
timeFrame: Beginning until after 9 months
measure: Health Assessment Questionnaire Disability Index (HAQ-DI) (NIS specialists)
timeFrame: Beginning until after 9 months
measure: Laboratory results (c reactive protein [CRP], BSG), X-rays (if available)
timeFrame: Beginning until after 9 months
measure: Side-effects and undesirable events
timeFrame: Beginning until after 9 months
Other outcomes:
Locations:
city: Darmstadt
country: Germany
facility: Merck Serono GmbH, Darmstadt, Germany
Study officials:
affiliation: Merck Serono GmbH, Germany
name: Dr. Boris Pfeiffer, M.Sc.
role: STUDY_DIRECTOR
References:
citation: 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.