A Multi-Center Trial to Compare Three Doses of Meloxicam and Placebo in Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00042068
First received: July 22, 2002
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Arthritis, Rheumatoid
Drug: Meloxicam
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Response according to American College of Rheumatology 20% (ACR20) classification [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of painful or tender joints [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Number of swollen joints [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Patient's global (overall) assessment of disease activity [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Investigator's global (overall) assessment of disease activity [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Patient's assessment of pain [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Patient's assessment of physical function (mHAQ) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • C-Reactive Protein (CRP) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Withdrawal due to lack of efficacy [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Duration of morning stiffness [ Time Frame: up to of 12 weeks ] [ Designated as safety issue: No ]
  • Patient's final global (overall) assessment of efficacy [ Time Frame: at end of 12 weeks ] [ Designated as safety issue: No ]
  • Investigator's final global (overall) assessment of efficacy [ Time Frame: at end of 12 weeks ] [ Designated as safety issue: No ]
  • Patient status with regard to change in arthritic condition [ Time Frame: at end of 12 weeks ] [ Designated as safety issue: No ]
  • Use of rescue medication [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Incidence and intensity of adverse events [ Time Frame: until 4 weeks post treatment ] [ Designated as safety issue: No ]
  • Patient's final global assessment of tolerability [ Time Frame: at end of 12 weeks ] [ Designated as safety issue: No ]
  • Investigator's final global assessment of tolerability [ Time Frame: at end of 12 weeks ] [ Designated as safety issue: No ]
  • Withdrawals due to adverse events [ Time Frame: at end of 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: June 2002
Estimated Study Completion Date: July 2003
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00042068

  Show 153 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim Ltd./Bracknell
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00042068     History of Changes
Other Study ID Numbers: 107.258
Study First Received: July 22, 2002
Last Updated: October 31, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Meloxicam
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 15, 2014