OsteoarthritisNCT00619177

Assessing the Impact of MOVALIS in Osteoarthritis and Rheumatoid Arthritis Patients on Health Related Quality of Life

An observational study of Osteoarthritis and Arthritis, Rheumatoid, run by Boehringer Ingelheim at 319 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Osteoarthritis, Arthritis, Rheumatoid
How many people: 3,569 participants
Where: 319 sitesin 5 countries
Study dates: Mar 2007to May 2008
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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: primary care and rheumatology clinics

Inclusion Criteria (according to Summary of Product Characteristics (SPC) ):

Male or female patients aged 18 years or above 2 Females of child bearing age must be using adequate contraception (hormonal or barrier method of birth control) 3. Patients with symptoms of acute, painful osteoarthritis or rheumatoid arthritis 4. Patients requiring therapy with non-steroidal anti-inflammatory drugs (NSAIDs) 5. Patients requiring either parenteral and/or oral NSAIDs 6. Patients who have not taken another NSAID or Cyclo-oxygenase-2 (COX-2) inhibitor in the previous 7 days Pain intensity on the visual analogue scale (VAS) 25 mm and above

Exclusion Criteria (according to contraindications of Summary of Product Characteristics (SPC) ):

Known hypersensitivity to meloxicam or any excipient of the product, known or suspected hypersensitivity to analgesics, antipyretics or NSAIDs
Patients who have developed signs of asthma, nasal polyps, angio-oedema or urticaria following the administration of aspirin or other NSAIDs
Active peptic ulcer, gastrointestinal perforation or bleeding within the last 6 months
Severe liver failure
Non-dialysed severe renal failure
Pregnancy or breastfeeding
Haemostasis disorders or concomitant treatment with anticoagulants
Severe congestive heart failure

Trial locations and contacts

319 sites in 5 countries.

Country

City, postcode or hospital

319 sites in 5 countries

Czechia253 sites

Boehringer Ingelheim Investigational Site
Aš
Boehringer Ingelheim Investigational Site
Babice
Boehringer Ingelheim Investigational Site
Benátky nad Jizerou
Boehringer Ingelheim Investigational Site
Benešov
Boehringer Ingelheim Investigational Site
Benesov Nad Ploucnicí
Boehringer Ingelheim Investigational Site
Benesov U Prahy
Boehringer Ingelheim Investigational Site
Beroun
Boehringer Ingelheim Investigational Site
Bílina
Boehringer Ingelheim Investigational Site
Bílovec
Boehringer Ingelheim Investigational Site
Bílovice nad Svitavou
Boehringer Ingelheim Investigational Site
Blansko
Boehringer Ingelheim Investigational Site
Blatnice pod Svatým Antonínkem
Boehringer Ingelheim Investigational Site
Bohusovice Nad Ohrí
Boehringer Ingelheim Investigational Site
Bolatice
Boehringer Ingelheim Investigational Site
Boskovice
Boehringer Ingelheim Investigational Site
Bratríkov
Boehringer Ingelheim Investigational Site
Břeclav
Boehringer Ingelheim Investigational Site
Brno
Boehringer Ingelheim Investigational Site
Broumov
Boehringer Ingelheim Investigational Site
Bruntál
Boehringer Ingelheim Investigational Site
Buchlovice
Boehringer Ingelheim Investigational Site
Byšice
Boehringer Ingelheim Investigational Site
Bystřice nad Pernštejnem
Boehringer Ingelheim Investigational Site
Cáslav
Boehringer Ingelheim Investigational Site
Černošice
Boehringer Ingelheim Investigational Site
Černožice
Boehringer Ingelheim Investigational Site
Ceská Lípa
Boehringer Ingelheim Investigational Site
Ceská Trebová
Boehringer Ingelheim Investigational Site
Ceské Budojovice
Boehringer Ingelheim Investigational Site
Ceský Tesín
Boehringer Ingelheim Investigational Site
Cheb
Boehringer Ingelheim Investigational Site
Chodov
Boehringer Ingelheim Investigational Site
Chomutov
Boehringer Ingelheim Investigational Site
Chropyně
Boehringer Ingelheim Investigational Site
Chrudim
Boehringer Ingelheim Investigational Site
Decín
Boehringer Ingelheim Investigational Site
Dobřany
Boehringer Ingelheim Investigational Site
Dobrís
Boehringer Ingelheim Investigational Site
Dobruška
Boehringer Ingelheim Investigational Site
Dol . Lou.
Boehringer Ingelheim Investigational Site
Dolní Benesov
Boehringer Ingelheim Investigational Site
Dolní Berkovice
Boehringer Ingelheim Investigational Site
Domažlice
Boehringer Ingelheim Investigational Site
Drnovice
Boehringer Ingelheim Investigational Site
Dvur Králové Nad Labem
Boehringer Ingelheim Investigational Site
Frenstát
Boehringer Ingelheim Investigational Site
Frýdek-Místek
Boehringer Ingelheim Investigational Site
Frýdlant
Boehringer Ingelheim Investigational Site
Fryštát
Boehringer Ingelheim Investigational Site
Fulnek
Boehringer Ingelheim Investigational Site
Hanušovice
Boehringer Ingelheim Investigational Site
Havírov
Boehringer Ingelheim Investigational Site
Havlíckuv Brod
Boehringer Ingelheim Investigational Site
Heřmanův Městec
Boehringer Ingelheim Investigational Site
Hlucín
Boehringer Ingelheim Investigational Site
Hluk
Boehringer Ingelheim Investigational Site
Hodonice
Boehringer Ingelheim Investigational Site
Hodonín
Boehringer Ingelheim Investigational Site
Holešov
Boehringer Ingelheim Investigational Site
Holice
Boehringer Ingelheim Investigational Site
Horice V Podkrkonosí
Boehringer Ingelheim Investigational Site
Horní Berkovice
Boehringer Ingelheim Investigational Site
Horní Slavkov
Boehringer Ingelheim Investigational Site
Hořovice
Boehringer Ingelheim Investigational Site
Hostinné
Boehringer Ingelheim Investigational Site
Hošťka
Boehringer Ingelheim Investigational Site
Hradec Králové
Boehringer Ingelheim Investigational Site
Hrádek n.N.
Boehringer Ingelheim Investigational Site
Hronov
Boehringer Ingelheim Investigational Site
Hrušovany nad Jevišovkou
Boehringer Ingelheim Investigational Site
Hulín
Boehringer Ingelheim Investigational Site
Hustopeče
Boehringer Ingelheim Investigational Site
Hustopece U Brna
Boehringer Ingelheim Investigational Site
Jablonec
Boehringer Ingelheim Investigational Site
Jablonec n.N.
Boehringer Ingelheim Investigational Site
Jablunkov
Boehringer Ingelheim Investigational Site
Jaroměř
Boehringer Ingelheim Investigational Site
Javorník
Boehringer Ingelheim Investigational Site
Jeseník
Boehringer Ingelheim Investigational Site
Jicín
Boehringer Ingelheim Investigational Site
Jihlava
Boehringer Ingelheim Investigational Site
Jirkov
Boehringer Ingelheim Investigational Site
Kadaň
Boehringer Ingelheim Investigational Site
Kaplice
Boehringer Ingelheim Investigational Site
Karlovy Vary
Boehringer Ingelheim Investigational Site
Kladno
Boehringer Ingelheim Investigational Site
Klásterec N. Ohrí
Boehringer Ingelheim Investigational Site
Klatovy
Boehringer Ingelheim Investigational Site
Klobouky u Brna
Boehringer Ingelheim Investigational Site
Kolín
Boehringer Ingelheim Investigational Site
Konice
Boehringer Ingelheim Investigational Site
Kopřivnice
Boehringer Ingelheim Investigational Site
Kosmonosy
Boehringer Ingelheim Investigational Site
Kostelec nad Orlicí
Boehringer Ingelheim Investigational Site
Kralupy nad Vltavou
Boehringer Ingelheim Investigational Site
Králuv Dvur
Boehringer Ingelheim Investigational Site
Krnov
Boehringer Ingelheim Investigational Site
Kromeríz
Boehringer Ingelheim Investigational Site
Krouna
Boehringer Ingelheim Investigational Site
Krupka
Boehringer Ingelheim Investigational Site
Kunovice
Boehringer Ingelheim Investigational Site
Kuřim
Boehringer Ingelheim Investigational Site
Kyjov
Boehringer Ingelheim Investigational Site
Lanškroun
Boehringer Ingelheim Investigational Site
Ledec Nad Sázavou
Boehringer Ingelheim Investigational Site
Lenešice
Boehringer Ingelheim Investigational Site
Letohrad
Boehringer Ingelheim Investigational Site
Liberec
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Liběšice
Boehringer Ingelheim Investigational Site
Libochovice
Boehringer Ingelheim Investigational Site
Lipová Lázne
Boehringer Ingelheim Investigational Site
Litoměřice
Boehringer Ingelheim Investigational Site
Litovel
Boehringer Ingelheim Investigational Site
Litvínov
Boehringer Ingelheim Investigational Site
Lomnice n.P.
Boehringer Ingelheim Investigational Site
Louny
Boehringer Ingelheim Investigational Site
Lovosice
Boehringer Ingelheim Investigational Site
Ludgérovice
Boehringer Ingelheim Investigational Site
Mariánské Lázne
Boehringer Ingelheim Investigational Site
Melník
Boehringer Ingelheim Investigational Site
Město Albrechtice
Boehringer Ingelheim Investigational Site
Milín
Boehringer Ingelheim Investigational Site
Milovice
Boehringer Ingelheim Investigational Site
Míretice
Boehringer Ingelheim Investigational Site
Mladá Boleslav
Boehringer Ingelheim Investigational Site
Mlázovice
Boehringer Ingelheim Investigational Site
Mnísek Pod Brdy
Boehringer Ingelheim Investigational Site
Modřice
Boehringer Ingelheim Investigational Site
Mohelnice
Boehringer Ingelheim Investigational Site
Mor.Budejovice
Boehringer Ingelheim Investigational Site
Mor.Krumlov
Boehringer Ingelheim Investigational Site
Mor.Nová Ves
Boehringer Ingelheim Investigational Site
Moravany
Boehringer Ingelheim Investigational Site
Most
Boehringer Ingelheim Investigational Site
Mýto
Boehringer Ingelheim Investigational Site
Náchod
Boehringer Ingelheim Investigational Site
Námest Nad Oslavou
Boehringer Ingelheim Investigational Site
Nasavrky
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Nechanice
Boehringer Ingelheim Investigational Site
Neratovice
Boehringer Ingelheim Investigational Site
Nová Ves Pod Plesí
Boehringer Ingelheim Investigational Site
Nové Mesto Nad Metují
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Nový Bor
Boehringer Ingelheim Investigational Site
Nový Bydzov
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Nový Jicín
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Nový Knín
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Nymburk
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Obrataň
Boehringer Ingelheim Investigational Site
Obríství
Boehringer Ingelheim Investigational Site
Olomouc
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Opava
Boehringer Ingelheim Investigational Site
Opočno
Boehringer Ingelheim Investigational Site
Orlová
Boehringer Ingelheim Investigational Site
Ostrava
Boehringer Ingelheim Investigational Site
Otrokovice
Boehringer Ingelheim Investigational Site
Pacov
Boehringer Ingelheim Investigational Site
Pardubice
Boehringer Ingelheim Investigational Site
Pelhřimov
Boehringer Ingelheim Investigational Site
Petřvald
Boehringer Ingelheim Investigational Site
Pierov
Boehringer Ingelheim Investigational Site
Pilsen
Boehringer Ingelheim Investigational Site
Písek
Boehringer Ingelheim Investigational Site
Planá
Boehringer Ingelheim Investigational Site
Polná
Boehringer Ingelheim Investigational Site
Postoloprty
Boehringer Ingelheim Investigational Site
Postřelmov
Boehringer Ingelheim Investigational Site
Prachatice
Boehringer Ingelheim Investigational Site
Prague
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Přelouč
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Přeštice
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Príbram
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Prostějov
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Radonice
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Rakovník
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Raspenava
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Řevnice
Boehringer Ingelheim Investigational Site
Rícany U Brna
Boehringer Ingelheim Investigational Site
Rokycany
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Roudnice nad Labem
Boehringer Ingelheim Investigational Site
Rožnov pod Radhoštěm
Boehringer Ingelheim Investigational Site
Ruda nad Moravou
Boehringer Ingelheim Investigational Site
Rudná U Prahy
Boehringer Ingelheim Investigational Site
Rumburk
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Rychnov nad Kněžnou
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Rýmarov
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Šaratice
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Semily
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Senov U NJ
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Skuteč
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Slaný
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Slatiňany
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Slavicín
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Slušovice
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Smidary
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Smiřice
Boehringer Ingelheim Investigational Site
Sokolov
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Spálené Porící
Boehringer Ingelheim Investigational Site
Stáhlavy
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Staré Mesto
Boehringer Ingelheim Investigational Site
Starý Plzenec
Boehringer Ingelheim Investigational Site
Štěnovice
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Stetí
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Strakonice
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Stríbro
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Studená
Boehringer Ingelheim Investigational Site
Studénka
Boehringer Ingelheim Investigational Site
Šumperk
Boehringer Ingelheim Investigational Site
Svetlá Nad Sázavou
Boehringer Ingelheim Investigational Site
Tábor
Boehringer Ingelheim Investigational Site
Teplice
Boehringer Ingelheim Investigational Site
Tišnov
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Tlucná
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Toužim
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Trebíc
Boehringer Ingelheim Investigational Site
Tremosná
Boehringer Ingelheim Investigational Site
Třešť
Boehringer Ingelheim Investigational Site
Třinec
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Trutnov
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Tupesy
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Turnov
Boehringer Ingelheim Investigational Site
Uherské Hradiste
Boehringer Ingelheim Investigational Site
Uherský Brod
Boehringer Ingelheim Investigational Site
Ústek
Boehringer Ingelheim Investigational Site
Ústí nad Labem
Boehringer Ingelheim Investigational Site
Ústí nad Orlicí
Boehringer Ingelheim Investigational Site
Val.Bystrice
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Valasské Mezirící
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Vamberk
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Vápenná
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Varnsdorf
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Velká Bítes
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Velké Mezirící
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Velké Opatovice
Boehringer Ingelheim Investigational Site
Velké Porící
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Veselí nad Moravou
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Vintírov
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Vlašim
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Vodňany
Boehringer Ingelheim Investigational Site
Votice
Boehringer Ingelheim Investigational Site
Vrbno pod Pradědem
Boehringer Ingelheim Investigational Site
Vsetín
Boehringer Ingelheim Investigational Site
Vyškov
Boehringer Ingelheim Investigational Site
Vysoké Mýto
Boehringer Ingelheim Investigational Site
Zábieh
Boehringer Ingelheim Investigational Site
Žamberk
Boehringer Ingelheim Investigational Site
Zastávka
Boehringer Ingelheim Investigational Site
Žatec
Boehringer Ingelheim Investigational Site
Zbýsov
Boehringer Ingelheim Investigational Site
Zdár Nad Sázavou
Boehringer Ingelheim Investigational Site
Žinkovy
Boehringer Ingelheim Investigational Site
Žirovnice
Boehringer Ingelheim Investigational Site
Zlín
Boehringer Ingelheim Investigational Site
Znojmo

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Slovakia36 sites

Boehringer Ingelheim Investigational Site
Bánovce/Bebravou
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Bardejov
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Bošany
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Bran?
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Handlová
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Humenné
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Kežmarok
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Kluknava
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Košice
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Krompachy
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Liptovský Mikulás
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Malacky
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Martin
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Michalovce
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Námestovo
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Nitra
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Nove Mesto/Váhom
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Pies?any
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Poprad
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Prešov
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Ružomberok
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Saint ?ubov?a
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Se?ovská Polianka
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Senec
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Spisská Nová Ves
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Stará Turá
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Stropkov
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Svinia
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Topo??any
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Torna?a
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Trebišov
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Tren?ín
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Trhovište
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Parne
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Põlva
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Rakvere
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Sillamäe
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Russia13 sites

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Ivanovo
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Croatia2 sites

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About this study

Official title: Assessing the Impact of MOVALIS on Health Related Quality of Life

The objective of the observational study is to examine the effect of MOVALIS (Meloxicam) therapy on Health Related Quality of Life (HRQoL) in the diverse region of Central and Eastern Europe. The Medical Outcomes Study 12 Item Short Form Health Survey version 2 (SF-12v2) will be used as the instrument to measure any change in physical wellbeing (Physical Component Summary, PCS) and mental wellbeing (Mental Component Summary, MCS) of patients following MOVALIS (Meloxicam) therapy.

Conditions: Osteoarthritis, Arthritis, Rheumatoid
Medical subject headings: Osteoarthritis, Arthritis, Rheumatoid

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change in Medical Outcomes Study 12-item Short-Form Health Survey, Version 2 Score From Baseline to Final Visit.
Physical Component Summary (PCS) Mean Difference final-baseline score. The Medical Outcomes Study 12-item Short-Form Health Survey, version 2 (SF-12v2) was used as the instrument to measure any changes in physical wellbeing (physical component summary, PCS) and mental wellbeing (mental component summary, MCS) in patients taking MOVALIS® therapy for approximately 4 weeks. Worst value 0 (lowest wellbeing), best value 100 (highest wellbeing)
Measured: baseline and final visit (approximately 4 weeks)
Mean Change in SF 12 MCS Score From Baseline to Final Final Visit.Medical Outcomes Study 12-Item Short-Form Health Survey, Version 2
Mental Component Summary (MCS). Mean Difference final-baseline score. Worst value 0 (lowest wellbeing), best value 100 (highest wellbeing)
Measured: Baseline and final visit (approximately 4 weeks)

Secondary outcomes (3)

Change From Baseline of Pain Intensity on Visual Analogue Scale
The effect of MOVALIS® on reduction of pain intensity was assessed by the change from baseline in patient assessment of pain intensity on a Visual Analogue Scale (VAS) ranging from 0 (no pain) to 100 (severe pain)
Measured: Approximately four weeks of treatment
Patient Assessment of Efficacy
Patient assessment of general efficacy of MOVALIS® using a 5-point scale (1 excellent; 2 very good; 3 good; 4 fair; 5 poor) was performed at visit 2.
The patients have been placed into categories according to the points on a scale.
Measured: after approximately 4 weeks of treatment
Physician Assessment of Efficacy
Physician assessment of general efficacy of MOVALIS® using a 5-point scale (1 excellent; 2 very good; 3 good; 4 fair; 5 poor) was performed at visit 2.
The patients have been placed into categories according to the points on a scale.
Measured: after approximately 4 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2007May 2008

First posted20 Feb 2008 (estimated)
Study startMar 2007
Primary completionMay 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for OsteoarthritisStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
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: 3,569 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00619177
Sponsor's protocol ID: 107.273
Status last verified: Jan 2015
First submitted: 8 Feb 2008
Last updated: 16 Feb 2015
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessing the Impact of MOVALIS on Health Related Quality of Life
ClinicalTrials.gov ID: NCT00619177
Acronym / sponsor ID: 107.273
Conditions: Osteoarthritis, Arthritis, Rheumatoid
Study type: Observational
Recruitment status: Completed
Enrolment: 3,569 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Mar 2007
Primary completion: May 2008 (actual)
First posted: 20 Feb 2008 (estimated)
Results: Posted 18 Nov 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: primary care and rheumatology clinics

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Mean Change in Medical Outcomes Study 12-item Short-Form Health Survey, Version 2 Score From Baseline to Final Visit.
Time frame: baseline and final visit (approximately 4 weeks)
Physical Component Summary (PCS) Mean Difference final-baseline score. The Medical Outcomes Study 12-item Short-Form Health Survey, version 2 (SF-12v2) was used as the instrument to measure any changes in physical wellbeing (physical component summary, PCS) and mental wellbeing (mental component summary, MCS) in patients taking MOVALIS® therapy for approximately 4 weeks. Worst value 0 (lowest wellbeing), best value 100 (highest wellbeing)
Mean Change in SF 12 MCS Score From Baseline to Final Final Visit.Medical Outcomes Study 12-Item Short-Form Health Survey, Version 2
Time frame: Baseline and final visit (approximately 4 weeks)
Mental Component Summary (MCS). Mean Difference final-baseline score. Worst value 0 (lowest wellbeing), best value 100 (highest wellbeing)

3 secondary outcomes

Change From Baseline of Pain Intensity on Visual Analogue Scale
Time frame: Approximately four weeks of treatment
Patient Assessment of Efficacy
Time frame: after approximately 4 weeks of treatment
Physician Assessment of Efficacy
Time frame: after approximately 4 weeks of treatment

Results and safety

Results posted to the registry on 18 Nov 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection	3,569	3,061

Primary outcome: Mean Change in Medical Outcomes Study 12-item Short-Form Health Survey, Version 2 Score From Baseline to Final Visit.

Time frame: baseline and final visit (approximately 4 weeks). Mean (Standard Deviation). Unit: Units on a scale

Measure	Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection n = 3473
Value	11.2 (9.5)

Population analysed: A total of 3569 patients from five Central and Eastern Europe (CEE) countries were entered in the study. These patients were treated with MOVALIS® therapy and formed the treated set (TS). Of these, 3473 patients completed two visits and had a baseline and final score for SF-12v2 and formed the full analysis set (FAS).

Primary outcome: Mean Change in SF 12 MCS Score From Baseline to Final Final Visit.Medical Outcomes Study 12-Item Short-Form Health Survey, Version 2

Time frame: Baseline and final visit (approximately 4 weeks). Mean (Standard Deviation). Unit: Units on a scale

Measure	Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection n = 3473
Value	6.2 (10.1)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 weeks + 5 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection	0 of 3,569 (0%)	0 of 3,569 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

319 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Osteoarthritis and Arthritis, Rheumatoid, run by Boehringer Ingelheim at 319 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 16 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 319 sites in Czechia, Slovakia, Estonia, Russia, Croatia. 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?

Yes. Results are posted in the registry (first posted 18 Nov 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Change in Medical Outcomes Study 12-item Short-Form Health Survey, Version 2 Score From Baseline to Final Visit. (time frame: baseline and final visit (approximately 4 weeks)). The study lists 2 primary outcomes in all. 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 NCT00619177.

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 16 Feb 2015.