Arthritis, Rheumatoid Clinical Trial
Official title:
A Multi-center, Double-Blind, Randomized, Parallel-Group Trial to Compare the Efficacy and Safety of Three Doses of Meloxicam (7.5, 15, and 22.5 mg) and Placebo in Patients With Rheumatoid Arthritis
| Verified date | October 2013 |
| Source | Boehringer Ingelheim |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
A 12-week trial consisting of 5 visits (6 if follow up is needed) to find out how effective and safe three different doses of meloxicam are compared with placebo in Rheumatoid Arthritis. Patient will take one dose of study medication daily.
| Status | Completed |
| Enrollment | 1000 |
| Est. completion date | July 2003 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Age greater than or equal to 18 and less than or equal to 80 - Diagnosis of Rheumatoid Arthritis for at least six weeks - Taking an NSAID - If female: using adequate contraception - Willingness to stop current NSAID until criteria reached to begin study drug - Able to provide written informed consent Exclusion Criteria: - Intolerance or hypersensitivity to NSAIDs or ingredients of trial drug - Pregnancy, lactating - Use of investigational drug within 30 days prior to entering the trial - History of peptic ulcer or of gastrointestinal hemorrhage except simple hemorrhoidal bleeding - History of cerebrovascular or other bleeding disorder - Severe hypertension - Other disease that might interfere with safety of the patient or evaluation of trial drug (investigator's opinion) - RA of functional class IV - Synovectomy in any large joint within the past 6 months prior to entering the trial or planned during trial - Concomitant therapy with anticoagulant, therapeutic doses of aspirin, phenothiazines, lithium, chronic GI-medication, analgesic drug (except acetaminophen up to 4 grams/day) - DMARDs initiated within past three months or dose changed less than two months before entering the trial - Therapy with corticosteroids exceeding 10 mg/day prednisone equivalent or change in dose within 1 month before trial - Concomitant therapy with ACTH within past month before entering the trial. - History of narcotic or alcohol abuse (past 12 months) - Abnormal laboratory values - Previous participation in the present trial |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Boehringer Ingelheim Investigational Site | Buenos Aires | |
| Argentina | Boehringer Ingelheim Investigational Site | Buenos Aires | |
| Argentina | Boehringer Ingelheim Investigational Site | Buenos Aires | |
| Argentina | Boehringer Ingelheim Investigational Site | Rosario | |
| Australia | Boehringer Ingelheim Investigational Site | Cotton Tree | Queensland |
| Australia | Emeritus Research | Malvern | Victoria |
| Australia | Department of Rheumatology | Perth | Western Australia |
| Belgium | Clinique du Parc Léopold | Bruxelles | |
| Belgium | Medisch Centrum van Huisartsen | Leuven | |
| Brazil | Av Anhanguera 6479 | Goiânia GO | |
| Brazil | Rua Ramiro Barcelos 2350 | Porto Alegre RS | |
| Brazil | Boehringer Ingelheim Investigational Site | São Paulo - SP | |
| Brazil | Clínica de Doenças Parasitárias e Infecciosas-Hospital Dia | São Paulo - SP | |
| Canada | Boehringer Ingelheim Investigational Site | Corunna | Ontario |
| Canada | Boehringer Ingelheim Investigational Site | Fort Erie | Ontario |
| Canada | Boehringer Ingelheim Investigational Site | Hamilton | Ontario |
| Canada | Dr. Denis O'Donnell | Kingston | Ontario |
| Canada | Trillium Health Centre | Mississauga | Ontario |
| Canada | Boehringer Ingelheim Investigational Site | Montreal | Quebec |
| Canada | Boehringer Ingelheim Investigational Site | Montreal | Quebec |
| Canada | Boehringer Ingelheim Investigational Site | Ottawa | Ontario |
| Canada | Boehringer Ingelheim Investigational Site | Peterborough | Ontario |
| Canada | Boehringer Ingelheim Investigational Site | Pointe-Claire | Quebec |
| Canada | 230-6091 | Richmond | British Columbia |
| Canada | Boehringer Ingelheim Investigational Site | Sarnia | Ontario |
| Canada | Boehringer Ingelheim Investigational Site | Scarborough | Ontario |
| Canada | 104-532 | St. Catharines | Ontario |
| Canada | Boehringer Ingelheim Investigational Site | Toronto | Ontario |
| Canada | Boehringer Ingelheim Investigational Site | Victoria | British Columbia |
| Canada | Boehringer Ingelheim Investigational Site | Windsor | Ontario |
| France | Boehringer Ingelheim Investigational Site | Marseille | |
| France | Boehringer Ingelheim Investigational Site | Nice | |
| France | Boehringer Ingelheim Investigational Site | Tours | |
| France | Boehringer Ingelheim Investigational Site | Tours cedex 9 | |
| Germany | Boehringer Ingelheim Investigational Site | Aachen | |
| Germany | Augusta-Klinik | Bad Kreuznach | |
| Germany | Boehringer Ingelheim Investigational Site | Bad Segeberg | |
| Germany | Rheumatologie und Physikalische Therapie | Berlin | |
| Germany | Boehringer Ingelheim Investigational Site | Ellefeld | |
| Germany | Elisabeth-Krankenhaus | Essen | |
| Germany | Boehringer Ingelheim Investigational Site | Klotten | |
| Germany | ClinPharm International GmbH & Co. KG | Leipzig | |
| Germany | Boehringer Ingelheim Investigational Site | München | |
| Germany | Boehringer Ingelheim Investigational Site | Nürnberg | |
| Germany | Boehringer Ingelheim Investigational Site | Nürnberg | |
| Germany | Boehringer Ingelheim Investigational Site | Steinhöring | |
| Germany | Boehringer Ingelheim Investigational Site | Tübingen | |
| Germany | Klinik für Rheumatologie, | Wiesbaden | |
| Hungary | National Institute for Rheumatology and Physiotherapy | Budapest | |
| Hungary | DOTE | Debrecen | |
| Hungary | Aladár Petz County Hospital | Györ | |
| Hungary | St. Andrew State Hospital | Hévíz | |
| Hungary | St. Ferenc Hospital | Miskolc | |
| Hungary | Pál Almási Balogh Hospital | Ózd | |
| Hungary | Hungarian Brothers of St. John of Good | Pecs | |
| Hungary | Szegedi University | Szeged | |
| Hungary | Ferenc Csolnoky County Hospital | Veszprem | |
| Italy | Università degli Studi | Genova | |
| Italy | Ospedale Augusto Murri | Jesi | |
| Italy | Università degli Studi di Napoli "Federico II" | Napoli | |
| Italy | Ospedale A. Galateo | SAN CESARIO (Lecce) | |
| Korea, Republic of | 896 Pyung Chon-Dong, Dongan-Gu | Gyeonggi-Do | |
| Korea, Republic of | San-5, Woncheon-Dong, Paldal-Gu | Gyeonggi-Do | |
| Korea, Republic of | 85 Jeo-Dong 2Ga | Seoul | |
| Korea, Republic of | Boehringer Ingelheim Investigational Site | Seoul | |
| Korea, Republic of | Seoul National University Hospital | Seoul | |
| Russian Federation | City Clinical Hospital No. 1 | Moscow | |
| Russian Federation | Institute of Rheumatology of RAMN | Moscow | |
| Taiwan | Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung | |
| Taiwan | Rheumatology-Allergy-Immunology | Kaohsiung | |
| Taiwan | Chang Gung Memorial Hospital | Taipei | |
| Taiwan | Taipei Veterans General Hospital | Taipei | |
| Ukraine | Dnyepropyetrovsk Medical Academy | Dnyepropetrovsk | |
| Ukraine | Central City Hospital | Donetsk | |
| Ukraine | State Medical University | Donetsk | |
| Ukraine | City Multitype Clinical Hospital No. 25 | Kharkov | |
| Ukraine | Municipal Institute of Health Care | Kharkov | |
| Ukraine | Central Clinical Hospital | Kiev | |
| Ukraine | Institute of Cardiology | Kiev | |
| Ukraine | Regional Hospital No. 1 | Kiev | |
| Ukraine | Institute of Gerontology | Kyiv | |
| United States | Suite 140 | Anchorage | Alaska |
| United States | Boehringer Ingelheim Investigational Site | Austin | Texas |
| United States | Boehringer Ingelheim Investigational Site | Camp Hill | Pennsylvania |
| United States | Suite 100 | Charlotte | North Carolina |
| United States | Boehringer Ingelheim Investigational Site | Coeur d'Alene | Idaho |
| United States | Suite 200 | Colorado Springs | Colorado |
| United States | Boehringer Ingelheim Investigational Site | Columbia | South Carolina |
| United States | Boehringer Ingelheim Investigational Site | Columbus | Ohio |
| United States | Boehringer Ingelheim Investigational Site | Dallas | Texas |
| United States | Radiant Research | Dallas | Texas |
| United States | Suite 200 | Dallas | Texas |
| United States | Suites 205 & 206 | Danbury | Connecticut |
| United States | Boehringer Ingelheim Investigational Site | Del Ray Beach | Florida |
| United States | Altoona Center for Clinical Research | Duncansville | Pennsylvania |
| United States | Boehringer Ingelheim Investigational Site | Erie | Pennsylvania |
| United States | Boehringer Ingelheim Investigational Site | Everett | Washington |
| United States | Truesdale Clinic | Fall River | Massachusetts |
| United States | Suite 2A | Falls Church | Virginia |
| United States | Boehringer Ingelheim Investigational Site | Gainsville | Florida |
| United States | #106 | Glendale | Arizona |
| United States | Suites 570 (research) & 600 (PI) | Huntsville | Alabama |
| United States | Suite 202 | Idaho Falls | Idaho |
| United States | Boehringer Ingelheim Investigational Site | Indianapolis | Indiana |
| United States | Boehringer Ingelheim Investigational Site | Jacksonville | Florida |
| United States | Suite 331-333 | Johnston | Rhode Island |
| United States | Suite 202 | Kalamazoo | Michigan |
| United States | Boehringer Ingelheim Investigational Site | Lake Forest | Illinois |
| United States | Boehringer Ingelheim Investigational Site | Largo | Florida |
| United States | Boehringer Ingelheim Investigational Site | Lincoln | Nebraska |
| United States | Boehringer Ingelheim Investigational Site | Los Angeles | California |
| United States | Suite 500 | Lubbock | Texas |
| United States | Suite D | Mechanicsburg | Pennsylvania |
| United States | PC, Jackson Commons D-2 | Medford | New Jersey |
| United States | Suite 8 | Mercerville | New Jersey |
| United States | Suite 202 | Miami | Florida |
| United States | Suite 200 | Montgomery | Alabama |
| United States | Boehringer Ingelheim Investigational Site | New York | New York |
| United States | Suite H | North Charleston | South Carolina |
| United States | Boehringer Ingelheim Investigational Site | Ocala | Florida |
| United States | Renstar Medical Research | Ocala | Florida |
| United States | Boehringer Ingelheim Investigational Site | Orangeburg | South Carolina |
| United States | Boehringer Ingelheim Investigational Site | Orlando | Florida |
| United States | Suite 2 | Orlando | Florida |
| United States | Boehringer Ingelheim Investigational Site | Pasadena | California |
| United States | Suite 201 | Phoenix | Arizona |
| United States | Suite 601 | Phoenix | Arizona |
| United States | Suite 100 | Rancho Cucamonga | California |
| United States | Boehringer Ingelheim Investigational Site | Rancho Mirage | California |
| United States | Boehringer Ingelheim Investigational Site | Reno | Nevada |
| United States | Boehringer Ingelheim Investigational Site | Rockford | Illinois |
| United States | Suite 406 | Safety Harbor | Florida |
| United States | Suites 207 | San Antonio | Texas |
| United States | Suite 202 | San Diego | California |
| United States | Suite 208 | San Diego | California |
| United States | Suite 301 | San Leandro | California |
| United States | Suite A | Santa Maria | California |
| United States | Boehringer Ingelheim Investigational Site | Sarasota | Florida |
| United States | Suite D-3 | Seattle | Washington |
| United States | Boehringer Ingelheim Investigational Site | South Miami | Florida |
| United States | Boehringer Ingelheim Investigational Site | Springfield | Illinois |
| United States | Suite 101 | St. Louis | Missouri |
| United States | Suite 240 | St. Louis | Missouri |
| United States | Suite 101 | St. Petersburg | Florida |
| United States | Radiant Research | Stuart | Florida |
| United States | Suite 203 | Tampa | Florida |
| United States | Boehringer Ingelheim Investigational Site | Tulsa | Oklahoma |
| United States | Suite 300 | Washington | District of Columbia |
| United States | Westlake Medical Research | Westlake Village | California |
| United States | Suite 306 | Wheaton | Maryland |
| United States | Attn: Kathy Stoddard, Director | Wichita | Kansas |
| United States | Boehringer Ingelheim Investigational Site | Yakima | Washington |
| United States | Boehringer Ingelheim Investigational Site | Zephyrhills | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
United States, Argentina, Australia, Belgium, Brazil, Canada, France, Germany, Hungary, Italy, Korea, Republic of, Russian Federation, Taiwan, Ukraine,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Response according to American College of Rheumatology 20% (ACR20) classification | at 12 weeks | No | |
| Secondary | Number of painful or tender joints | up to 12 weeks | No | |
| Secondary | Number of swollen joints | up to 12 weeks | No | |
| Secondary | Patient's global (overall) assessment of disease activity | up to 12 weeks | No | |
| Secondary | Investigator's global (overall) assessment of disease activity | up to 12 weeks | No | |
| Secondary | Patient's assessment of pain | up to 12 weeks | No | |
| Secondary | Patient's assessment of physical function (mHAQ) | up to 12 weeks | No | |
| Secondary | C-Reactive Protein (CRP) | up to 12 weeks | No | |
| Secondary | Withdrawal due to lack of efficacy | up to 12 weeks | No | |
| Secondary | Duration of morning stiffness | up to of 12 weeks | No | |
| Secondary | Patient's final global (overall) assessment of efficacy | at end of 12 weeks | No | |
| Secondary | Investigator's final global (overall) assessment of efficacy | at end of 12 weeks | No | |
| Secondary | Patient status with regard to change in arthritic condition | at end of 12 weeks | No | |
| Secondary | Use of rescue medication | up to 12 weeks | No | |
| Secondary | Incidence and intensity of adverse events | until 4 weeks post treatment | No | |
| Secondary | Patient's final global assessment of tolerability | at end of 12 weeks | No | |
| Secondary | Investigator's final global assessment of tolerability | at end of 12 weeks | No | |
| Secondary | Withdrawals due to adverse events | at end of 12 weeks | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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