Arthritis, Rheumatoid Clinical Trial
Official title:
A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg Administered Orally Once Daily, in Adults With Rheumatoid Arthritis
| Verified date | March 2017 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study is being conducted to find out if an investigational drug called GW406381 can help people with rheumatoid arthritis.
| Status | Completed |
| Enrollment | 2208 |
| Est. completion date | September 2006 |
| Est. primary completion date | September 2006 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion criteria: - Rheumatoid arthritis (RA) for at least 12 months. - Required a non-steroidal anti-inflammatory drug (NSAID) or COX-2 inhibitor for RA for at least 5 out of 7 days of each week for the 4 weeks prior to screening. Exclusion criteria: - Any history of cardiovascular disease (e.g., heart attack, stroke, congestive heart failure, uncontrolled high blood pressure), documented peripheral arterial insufficiency and symptomatic, clinically significant claudication, or who have a history of peripheral arterial embolism. - Have an active stomach ulcer or history of any stomach tear or bleeding. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | GSK Investigational Site | Ciudad Autónoma de Buenos Aires | |
| Argentina | GSK Investigational Site | Ciudad Autónoma de Buenos Aires | |
| Argentina | GSK Investigational Site | Ciudad Autónoma de Buenos Aires | |
| Argentina | GSK Investigational Site | Ciudad Autónoma de Buenos Aires | |
| Argentina | GSK Investigational Site | Ciudad Autónoma de Buenos Aires | |
| Argentina | GSK Investigational Site | Cordoba | |
| Argentina | GSK Investigational Site | Cordoba | Córdova |
| Argentina | GSK Investigational Site | Córdoba | Córdova |
| Argentina | GSK Investigational Site | Quilmes | |
| Argentina | GSK Investigational Site | Rosario | Santa Fe |
| Argentina | GSK Investigational Site | San Juan | |
| Argentina | GSK Investigational Site | Tucuman | |
| Austria | GSK Investigational Site | Vienna | |
| Austria | GSK Investigational Site | Vienna | |
| Austria | GSK Investigational Site | Vienna | |
| Austria | GSK Investigational Site | Vienna | |
| Belgium | GSK Investigational Site | Antwerpen | |
| Belgium | GSK Investigational Site | Diepenbeek | |
| Belgium | GSK Investigational Site | Lommel | |
| Belgium | GSK Investigational Site | Mons | |
| Bulgaria | GSK Investigational Site | Pleven | |
| Bulgaria | GSK Investigational Site | Sofia | |
| Bulgaria | GSK Investigational Site | Sofia | |
| Bulgaria | GSK Investigational Site | Sofia | |
| Bulgaria | GSK Investigational Site | Varna | |
| Canada | GSK Investigational Site | Edmonton | Alberta |
| Canada | GSK Investigational Site | Kitchener | Ontario |
| Canada | GSK Investigational Site | Mississauga | Ontario |
| Canada | GSK Investigational Site | Montreal | Quebec |
| Canada | GSK Investigational Site | Montreal | Quebec |
| Canada | GSK Investigational Site | Penticton | British Columbia |
| Canada | GSK Investigational Site | Saint John's | Newfoundland and Labrador |
| Canada | GSK Investigational Site | Sainte-Foy | Quebec |
| Canada | GSK Investigational Site | Saskatoon | Saskatchewan |
| Canada | GSK Investigational Site | St-Jerome | Quebec |
| Canada | GSK Investigational Site | Toronto | Ontario |
| Canada | GSK Investigational Site | Toronto | Ontario |
| Canada | GSK Investigational Site | Toronto | Ontario |
| Canada | GSK Investigational Site | Trois-Rivieres | Quebec |
| Canada | GSK Investigational Site | Victoria | British Columbia |
| Canada | GSK Investigational Site | Windsor | Ontario |
| Canada | GSK Investigational Site | Winnipeg | Manitoba |
| Chile | GSK Investigational Site | Santiago | Región Metro De Santiago |
| Chile | GSK Investigational Site | Santiago | Región Metro De Santiago |
| Chile | GSK Investigational Site | Viña del Mar | Valparaíso |
| Costa Rica | GSK Investigational Site | San Jose | |
| Denmark | GSK Investigational Site | Aalborg | |
| Denmark | GSK Investigational Site | Ishoj | |
| Denmark | GSK Investigational Site | Odense C | |
| Denmark | GSK Investigational Site | Vejle | |
| Finland | GSK Investigational Site | Helsinki | |
| Finland | GSK Investigational Site | Hyvinkaa | |
| Finland | GSK Investigational Site | Kuopio | |
| France | GSK Investigational Site | Angers | |
| France | GSK Investigational Site | Cahors cedex 9 | |
| France | GSK Investigational Site | Chilly Mazarin | |
| France | GSK Investigational Site | Corbeil Essonnes Cedex | |
| France | GSK Investigational Site | Grenoble cedex 09 | |
| France | GSK Investigational Site | Lyon | |
| France | GSK Investigational Site | Paris cedex 12 | |
| France | GSK Investigational Site | Toulouse | |
| France | GSK Investigational Site | Tours | |
| Germany | GSK Investigational Site | Aachen | Nordrhein-Westfalen |
| Germany | GSK Investigational Site | Baden-Baden | Baden-Wuerttemberg |
| Germany | GSK Investigational Site | Bayreuth | Bayern |
| Germany | GSK Investigational Site | Beckum | Nordrhein-Westfalen |
| Germany | GSK Investigational Site | Berlin | |
| Germany | GSK Investigational Site | Berlin | |
| Germany | GSK Investigational Site | Berlin | |
| Germany | GSK Investigational Site | Berlin | |
| Germany | GSK Investigational Site | Berlin | |
| Germany | GSK Investigational Site | Bochum | Nordrhein-Westfalen |
| Germany | GSK Investigational Site | Chemnitz | Sachsen |
| Germany | GSK Investigational Site | Deggingen | Baden-Wuerttemberg |
| Germany | GSK Investigational Site | Delitzsch | Sachsen |
| Germany | GSK Investigational Site | Dresden | Sachsen |
| Germany | GSK Investigational Site | Einbeck | Niedersachsen |
| Germany | GSK Investigational Site | Elmshorn | Schleswig-Holstein |
| Germany | GSK Investigational Site | Erlangen | Bayern |
| Germany | GSK Investigational Site | Essen | Nordrhein-Westfalen |
| Germany | GSK Investigational Site | Freiburg | Baden-Wuerttemberg |
| Germany | GSK Investigational Site | Freital | Sachsen |
| Germany | GSK Investigational Site | Goch | Nordrhein-Westfalen |
| Germany | GSK Investigational Site | Goerlitz | Sachsen |
| Germany | GSK Investigational Site | Hamburg | |
| Germany | GSK Investigational Site | Hamburg | |
| Germany | GSK Investigational Site | Hamburg | |
| Germany | GSK Investigational Site | Hannover | Niedersachsen |
| Germany | GSK Investigational Site | Hattingen | Nordrhein-Westfalen |
| Germany | GSK Investigational Site | Hildesheim | Niedersachsen |
| Germany | GSK Investigational Site | Huettenberg | Hessen |
| Germany | GSK Investigational Site | Kippenheim | Baden-Wuerttemberg |
| Germany | GSK Investigational Site | Koeln | Nordrhein-Westfalen |
| Germany | GSK Investigational Site | Leipzig | Sachsen |
| Germany | GSK Investigational Site | Leipzig | Sachsen |
| Germany | GSK Investigational Site | Luebeck | Schleswig-Holstein |
| Germany | GSK Investigational Site | Muenchen | Bayern |
| Germany | GSK Investigational Site | Muenchen | Bayern |
| Germany | GSK Investigational Site | Muenster | Nordrhein-Westfalen |
| Germany | GSK Investigational Site | Nuernberg | Bayern |
| Germany | GSK Investigational Site | Passau | Bayern |
| Germany | GSK Investigational Site | Pinneberg | Schleswig-Holstein |
| Germany | GSK Investigational Site | Rhaunen | Rheinland-Pfalz |
| Germany | GSK Investigational Site | Saarbruecken | Saarland |
| Germany | GSK Investigational Site | Schmiedeberg | Sachsen |
| Germany | GSK Investigational Site | Schwerin | Mecklenburg-Vorpommern |
| Germany | GSK Investigational Site | Stuttgart | Baden-Wuerttemberg |
| Germany | GSK Investigational Site | Stuttgart | Baden-Wuerttemberg |
| Germany | GSK Investigational Site | Weinheim | Baden-Wuerttemberg |
| Germany | GSK Investigational Site | Wiesbaden | Hessen |
| Germany | GSK Investigational Site | Witten | Nordrhein-Westfalen |
| Germany | GSK Investigational Site | Wolmirstedt | Sachsen-Anhalt |
| Greece | GSK Investigational Site | Kavala | |
| Greece | GSK Investigational Site | Thessaloniki | |
| Greece | GSK Investigational Site | Thessaloniki | |
| Greece | GSK Investigational Site | Thessaloniki | |
| Hungary | GSK Investigational Site | Budapest | |
| Hungary | GSK Investigational Site | Budapest | |
| Hungary | GSK Investigational Site | Budapest | |
| Hungary | GSK Investigational Site | Gyor | |
| India | GSK Investigational Site | Bangalore | |
| India | GSK Investigational Site | Bangalore | |
| India | GSK Investigational Site | Bangalore | |
| India | GSK Investigational Site | Chennai | |
| India | GSK Investigational Site | Hyderabad | |
| India | GSK Investigational Site | Hyderabad, Andhra Pradesh | |
| India | GSK Investigational Site | New Delhi | |
| India | GSK Investigational Site | Pune. | |
| Ireland | GSK Investigational Site | Dublin | |
| Ireland | GSK Investigational Site | Waterford | |
| Italy | GSK Investigational Site | Arenzano (GE) | Liguria |
| Italy | GSK Investigational Site | Benevento | Campania |
| Italy | GSK Investigational Site | Genova | Liguria |
| Italy | GSK Investigational Site | Montebelluna (TV) | Veneto |
| Italy | GSK Investigational Site | Pescara | Abruzzo |
| Italy | GSK Investigational Site | Pisa | Toscana |
| Italy | GSK Investigational Site | Prato | Toscana |
| Italy | GSK Investigational Site | Rozzano (MI) | Lombardia |
| Italy | GSK Investigational Site | Telese Terme (BN) | Campania |
| Italy | GSK Investigational Site | Terni | Umbria |
| Korea, Republic of | GSK Investigational Site | Anyang-Si | |
| Korea, Republic of | GSK Investigational Site | Daegu | |
| Korea, Republic of | GSK Investigational Site | Seoul | |
| Korea, Republic of | GSK Investigational Site | Seoul | |
| Korea, Republic of | GSK Investigational Site | Seoul | |
| Korea, Republic of | GSK Investigational Site | Seoul | |
| Latvia | GSK Investigational Site | Liepaja | |
| Latvia | GSK Investigational Site | Riga | |
| Latvia | GSK Investigational Site | Riga | |
| Latvia | GSK Investigational Site | Valmiera | |
| Mexico | GSK Investigational Site | Guadalajara | Jalisco |
| Mexico | GSK Investigational Site | Guadalajara | Jalisco |
| Mexico | GSK Investigational Site | Mexico | |
| Mexico | GSK Investigational Site | Mexico | |
| Mexico | GSK Investigational Site | Mexico, D.F. | |
| Mexico | GSK Investigational Site | Monterrey | Nuevo León |
| Netherlands | GSK Investigational Site | Den Haag | |
| Netherlands | GSK Investigational Site | Etten-leur | |
| Netherlands | GSK Investigational Site | Gouda | |
| Netherlands | GSK Investigational Site | Heerlen | |
| Netherlands | GSK Investigational Site | Nijmegen | |
| Netherlands | GSK Investigational Site | Zwolle | |
| New Zealand | GSK Investigational Site | Auckland | |
| New Zealand | GSK Investigational Site | Auckland | |
| New Zealand | GSK Investigational Site | Christchurch | |
| New Zealand | GSK Investigational Site | Lower Hutt | |
| New Zealand | GSK Investigational Site | Rotorua | |
| Norway | GSK Investigational Site | Harstad | |
| Norway | GSK Investigational Site | Levanger | |
| Norway | GSK Investigational Site | Lillehammer | |
| Norway | GSK Investigational Site | Skien | |
| Norway | GSK Investigational Site | Tønsberg | |
| Peru | GSK Investigational Site | Callao | |
| Peru | GSK Investigational Site | Lima | |
| Peru | GSK Investigational Site | Lima | |
| Philippines | GSK Investigational Site | Manila | |
| Philippines | GSK Investigational Site | Manila | |
| Poland | GSK Investigational Site | Grudziadz | |
| Poland | GSK Investigational Site | Poznan | |
| Poland | GSK Investigational Site | Warszawa | |
| Poland | GSK Investigational Site | Wroclaw | |
| Poland | GSK Investigational Site | Wroclaw | |
| Puerto Rico | GSK Investigational Site | Caguas | |
| Romania | GSK Investigational Site | Brasov | |
| Romania | GSK Investigational Site | Bucharest | |
| Romania | GSK Investigational Site | Bucharest | |
| Romania | GSK Investigational Site | Bucharest | |
| Russian Federation | GSK Investigational Site | Ekaterinburg | |
| Russian Federation | GSK Investigational Site | Moscow | |
| Russian Federation | GSK Investigational Site | Moscow | |
| Russian Federation | GSK Investigational Site | Moscow | |
| Russian Federation | GSK Investigational Site | Moscow | |
| Russian Federation | GSK Investigational Site | Ryazan | |
| Russian Federation | GSK Investigational Site | Sankt-Petersburg | |
| Russian Federation | GSK Investigational Site | Saratov | |
| Russian Federation | GSK Investigational Site | St. Petersburg | |
| Russian Federation | GSK Investigational Site | Tula | |
| Russian Federation | GSK Investigational Site | Yaroslavl | |
| Russian Federation | GSK Investigational Site | Yaroslavl | |
| South Africa | GSK Investigational Site | Boksburg | Gauteng |
| South Africa | GSK Investigational Site | Cape Town | |
| South Africa | GSK Investigational Site | Durban | |
| South Africa | GSK Investigational Site | Erasmus Kloof, Pretoria | |
| South Africa | GSK Investigational Site | Kempton Park | |
| South Africa | GSK Investigational Site | Korsten | Eastern Cape |
| South Africa | GSK Investigational Site | Muckleneuk | Gauteng |
| South Africa | GSK Investigational Site | Observatory | |
| South Africa | GSK Investigational Site | Parktown | Gauteng |
| South Africa | GSK Investigational Site | Pinetown | |
| Spain | GSK Investigational Site | Baracaldo/Vizcaya | |
| Spain | GSK Investigational Site | Barcelona | |
| Spain | GSK Investigational Site | Barcelona | |
| Spain | GSK Investigational Site | Barcelona | |
| Spain | GSK Investigational Site | Cordoba | |
| Spain | GSK Investigational Site | Granada | |
| Spain | GSK Investigational Site | Guadalajara | |
| Spain | GSK Investigational Site | La Coruña | |
| Spain | GSK Investigational Site | Mérida (Badajoz) | |
| Spain | GSK Investigational Site | Oviedo | |
| Spain | GSK Investigational Site | Pamplona | |
| Spain | GSK Investigational Site | San Sebastián | |
| Spain | GSK Investigational Site | Santiago de Compostela | |
| Spain | GSK Investigational Site | Sevilla | |
| Spain | GSK Investigational Site | Valencia | |
| Spain | GSK Investigational Site | Villajoyosa | |
| Ukraine | GSK Investigational Site | Kharkiv | |
| Ukraine | GSK Investigational Site | Kharkiv | |
| Ukraine | GSK Investigational Site | Kiev | |
| Ukraine | GSK Investigational Site | Kyiv | |
| Ukraine | GSK Investigational Site | Lviv | |
| United Kingdom | GSK Investigational Site | Ashford | Middlesex |
| United Kingdom | GSK Investigational Site | Manchester | Lancashire |
| United Kingdom | GSK Investigational Site | Northampton | Northamptonshire |
| United Kingdom | GSK Investigational Site | St Albans | Hertfordshire |
| United Kingdom | GSK Investigational Site | Truro | Cornwall |
| United Kingdom | GSK Investigational Site | Wirral | Merseyside |
| United States | GSK Investigational Site | Anaheim | California |
| United States | GSK Investigational Site | Anniston | Alabama |
| United States | GSK Investigational Site | Atlanta | Georgia |
| United States | GSK Investigational Site | Austin | Texas |
| United States | GSK Investigational Site | Aventura | Florida |
| United States | GSK Investigational Site | Berlin | New Jersey |
| United States | GSK Investigational Site | Birmingham | Alabama |
| United States | GSK Investigational Site | Birmingham | Alabama |
| United States | GSK Investigational Site | Bridgeport | Connecticut |
| United States | GSK Investigational Site | Charleston | South Carolina |
| United States | GSK Investigational Site | Charleston | South Carolina |
| United States | GSK Investigational Site | Charlotte | North Carolina |
| United States | GSK Investigational Site | Cleveland | Ohio |
| United States | GSK Investigational Site | Colorado Springs | Colorado |
| United States | GSK Investigational Site | Columbus | Ohio |
| United States | GSK Investigational Site | Concinnati | Ohio |
| United States | GSK Investigational Site | Dallas | Texas |
| United States | GSK Investigational Site | Danbury | Connecticut |
| United States | GSK Investigational Site | Daytona Beach | Florida |
| United States | GSK Investigational Site | Deland | Florida |
| United States | GSK Investigational Site | Dover | New Hampshire |
| United States | GSK Investigational Site | Duncansville | Pennsylvania |
| United States | GSK Investigational Site | Dunedin | Florida |
| United States | GSK Investigational Site | Evanston | Illinois |
| United States | GSK Investigational Site | Evansville | Indiana |
| United States | GSK Investigational Site | Everett | Washington |
| United States | GSK Investigational Site | Fall River | Massachusetts |
| United States | GSK Investigational Site | Gainsville | Georgia |
| United States | GSK Investigational Site | Gastonia | North Carolina |
| United States | GSK Investigational Site | Glendale | Arizona |
| United States | GSK Investigational Site | Greer | South Carolina |
| United States | GSK Investigational Site | Hamden | Connecticut |
| United States | GSK Investigational Site | Hampton | South Carolina |
| United States | GSK Investigational Site | Hickory | North Carolina |
| United States | GSK Investigational Site | Huntsville | Alabama |
| United States | GSK Investigational Site | Idaho Falls | Idaho |
| United States | GSK Investigational Site | Indianapolis | Indiana |
| United States | GSK Investigational Site | Indianapolis | Indiana |
| United States | GSK Investigational Site | Johnson City | New York |
| United States | GSK Investigational Site | Kalamazoo | Michigan |
| United States | GSK Investigational Site | Kingston | New York |
| United States | GSK Investigational Site | Lansing | Michigan |
| United States | GSK Investigational Site | Largo | Florida |
| United States | GSK Investigational Site | Las Vegas | Nevada |
| United States | GSK Investigational Site | Las Vegas | Nevada |
| United States | GSK Investigational Site | Las Vegas | Nevada |
| United States | GSK Investigational Site | Louisville | Kentucky |
| United States | GSK Investigational Site | Louisville | Kentucky |
| United States | GSK Investigational Site | Louisville | Kentucky |
| United States | GSK Investigational Site | Mayfield Village | Ohio |
| United States | GSK Investigational Site | Medford | Oregon |
| United States | GSK Investigational Site | Memphis | Tennessee |
| United States | GSK Investigational Site | Mercerville | New Jersey |
| United States | GSK Investigational Site | Miami | Florida |
| United States | GSK Investigational Site | Miami | Florida |
| United States | GSK Investigational Site | Montgomery | Alabama |
| United States | GSK Investigational Site | Montgomery | Alabama |
| United States | GSK Investigational Site | Morton Grove | Illinois |
| United States | GSK Investigational Site | Murrells Inlet | South Carolina |
| United States | GSK Investigational Site | New Orleans | Louisiana |
| United States | GSK Investigational Site | New York | New York |
| United States | GSK Investigational Site | North Massapequa | New York |
| United States | GSK Investigational Site | Ocala | Florida |
| United States | GSK Investigational Site | Oklahoma City | Oklahoma |
| United States | GSK Investigational Site | Orlando | Florida |
| United States | GSK Investigational Site | Orlando | Florida |
| United States | GSK Investigational Site | Palm Desert | California |
| United States | GSK Investigational Site | Palm Harbor | Florida |
| United States | GSK Investigational Site | Philadelphia | Pennsylvania |
| United States | GSK Investigational Site | Philadelphia | Pennsylvania |
| United States | GSK Investigational Site | Port Orange | Florida |
| United States | GSK Investigational Site | Prairie Village | Kansas |
| United States | GSK Investigational Site | Racine | Wisconsin |
| United States | GSK Investigational Site | Reno | Nevada |
| United States | GSK Investigational Site | Rochester | New York |
| United States | GSK Investigational Site | Roswell | Georgia |
| United States | GSK Investigational Site | San Antonio | Texas |
| United States | GSK Investigational Site | San Antonio | Texas |
| United States | GSK Investigational Site | San Diego | California |
| United States | GSK Investigational Site | San Diego | California |
| United States | GSK Investigational Site | San Diego | California |
| United States | GSK Investigational Site | Santa Monica | California |
| United States | GSK Investigational Site | Scottsdale | Arizona |
| United States | GSK Investigational Site | Slidell | Louisiana |
| United States | GSK Investigational Site | Springfield | Illinois |
| United States | GSK Investigational Site | Springfield | Massachusetts |
| United States | GSK Investigational Site | St. Louis | Missouri |
| United States | GSK Investigational Site | St. Louis | Missouri |
| United States | GSK Investigational Site | Statesville | North Carolina |
| United States | GSK Investigational Site | Stuart | Florida |
| United States | GSK Investigational Site | Tampa | Florida |
| United States | GSK Investigational Site | Trinity | Florida |
| United States | GSK Investigational Site | Trumbull | Connecticut |
| United States | GSK Investigational Site | Tucson | Arizona |
| United States | GSK Investigational Site | Tucson | Arizona |
| United States | GSK Investigational Site | Tulsa | Oklahoma |
| United States | GSK Investigational Site | Tulsa | Oklahoma |
| United States | GSK Investigational Site | Upland | California |
| United States | GSK Investigational Site | Vancouver | Washington |
| United States | GSK Investigational Site | West Palm Beach | Florida |
| United States | GSK Investigational Site | West Reading | Pennsylvania |
| United States | GSK Investigational Site | Wheaton | Maryland |
| United States | GSK Investigational Site | Wichita | Kansas |
| United States | GSK Investigational Site | Woodstock | Georgia |
| United States | GSK Investigational Site | Zephyrhills | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
United States, Argentina, Austria, Belgium, Bulgaria, Canada, Chile, Costa Rica, Denmark, Finland, France, Germany, Greece, Hungary, India, Ireland, Italy, Korea, Republic of, Latvia, Mexico, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Puerto Rico, Romania, Russian Federation, South Africa, Spain, Ukraine, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of American College of Rheumatology (ACR)20 Responders at Week 12 | Week 12 | ||
| Secondary | Change from baseline to each scheduled visit in tender/painful joint count (68 joint panel) | Baseline and Week 12 | ||
| Secondary | Change from baseline to each scheduled visit in swollen joint count (66 joint panel) | Baseline and Week 12 | ||
| Secondary | Change from baseline to each scheduled visit in patient's pain assessment (VAS) | Baseline and Week 12 | ||
| Secondary | Change from baseline to each scheduled visit in physician's global assessment of arthritis condition | Baseline and Week 12 | ||
| Secondary | Change from baseline to each scheduled visit in patient's global assessment of arthritis condition | Baseline and Week 12 | ||
| Secondary | Change from baseline to each scheduled visit in functional disability index (HAQ) | Baseline and Week 12 | ||
| Secondary | Change between baseline and end of treatment (or early withdrawal) in the Short Form - McGill Pain Questionnaire (SF-MPQ) | Baseline and Up to Week 12 | ||
| Secondary | Change from baseline to each scheduled visit in C-reactive protein (CRP) | Baseline and up to Week 12 | ||
| Secondary | Number of participants withdrawing from the study due to lack of efficacy | Week 12 | ||
| Secondary | Number of participants who received supplementary analgesic therapy | Week 12 | ||
| Secondary | Changes from pretreatment to on treatment and post-treatment follow-up in vital signs- systolic blood pressure (SBP) and diastolic blood pressure (DBP) | Baseline and up to Week 12 | ||
| Secondary | Changes from pretreatment to on treatment and post-treatment follow-up in vital signs- heart rate (HR) | Baseline and up to Week 12 | ||
| Secondary | Changes from pretreatment to on treatment and post-treatment follow-up in weight | Baseline and Week 12 | ||
| Secondary | Number of participants with change in BMI of potential clinical concern | Week 4, 4, 8, 12 and foloow up | ||
| Secondary | Number of participants with change from baseline of pedal oedema (including diuretic use) | Baseline and up to Week 12 | ||
| Secondary | Change from baseline in 12-lead electrocardiograms (ECGs) | Baseline and up to Week 12 | ||
| Secondary | Change from baseline in clinical chemistry parameters: Albumin | Baseline and up to Week 12 | ||
| Secondary | Change from baseline in clinical chemistry parameters: Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase | Baseline and Up to Week 12 | ||
| Secondary | Change from baseline in clinical chemistry parameters: Total Bilirubin | Baseline and up to Week 12 | ||
| Secondary | Change from baseline in clinical chemistry parameters: Carbon Dioxide content /Bicarbonate, Glucose, Potassium, Sodium | Baseline and up to Week 12 | ||
| Secondary | Change from baseline in clinical chemistry parameters: Creatinine | Baseline and up to Week 12 | ||
| Secondary | Change from baseline in haematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet count, White Blood Cell count | Baseline and up to Week 12 | ||
| Secondary | Change from baseline in haematology parameters: Hemoglobin | Baseline and up to Week 12 | ||
| Secondary | Change from baseline in haematology parameters: Mean Corpuscle volume | Baseline and Up to Week 12 | ||
| Secondary | Change from baseline in haematology parameters: Red Blood Cell count | Baseline and up to Week 12 | ||
| Secondary | Urinalysis assessment | Up to Week 12 | ||
| Secondary | Number of participants with adverse events (AEs) and serious adverse events (SAEs) | Upto Week 12 | ||
| Secondary | Change in the Short Form-36 (SF-36v2) subscale scores between baseline and the end of treatment (or early withdrawal) | Baseline and Week 12 | ||
| Secondary | Change in the Short Form-36 (SF-36v2) Physical component summary score and mental component summary score between baseline and the end of treatment (or early withdrawal) | Baseline and Week 12 | ||
| Secondary | Psychometrically test and validate the amended Patient Satisfaction with Pain Medication questionnaire | Week 12 | ||
| Secondary | Change between baseline and end of treatment (or early withdrawal) in the EuroQoL Questionnaire -5 Dimensions (EQ-5D) utility score, using European population utility tariff | Baseline and Week 12 | ||
| Secondary | Change between baseline and end of treatment (or early withdrawal) in the fatigue/inertia factor of the Profile of Moods States Brief Form (POMS-B) | Baseline and Week 12 |
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| Completed |
NCT00550446 -
A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis
|
Phase 2 |