A Study of the Patterns of Use of Etoricoxib in France (MK-0663-148) (COXIBUS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01572675
First received: February 3, 2012
Last updated: April 15, 2016
Last verified: April 2016
  Purpose
This postmarketing study will examine the use of etoricoxib (Arcoxia®) in routine clinical practice in France as well as the use of celecoxib (Celebrex®).

Condition Intervention
Osteoarthritis
Drug: etorocoxib
Drug: celecoxib

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacoepidemiological Study on the Use of Arcoxia® Under Actual Conditions of Use in France

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants Demonstrating Proper Use of Arcoxia® and Celebrex® [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Proper use of study medication is defined as administration of medication in terms of indication and dosage according to Market Authorization (MA). Proper use of Arcoxia® is defined as administration of a starting dose of 30 mg daily, not to exceed 60 mg daily during follow-up, for the treatment of symptoms of osteoarthritis. Proper use of Celebrex® is defined as administration of a starting dose of 200 mg daily, not to exceed 400 mg daily during follow-up, for easing symptoms in the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Data to assess proper use were collected through use of a medical questionnaire and patient form. Data pertaining to indication was collected by open-field to allow physicians to precisely indicate the reason for prescription. Recorded indications were then analyzed by two medical experts (an independent expert and a member of the Scientific Community) to assess proper use or misuse.

  • Reasons for Misuse of Arcoxia® and Celebrex® [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Proper use of study medication is defined as administration of medication in terms of indication and dosage according to MA. Proper use of Arcoxia® is defined as administration of a starting dose of 30 mg daily, not to exceed 60 mg daily during follow-up, for the treatment of symptoms of osteoarthritis. Proper use of Celebrex® is defined as administration of a starting dose of 200 mg daily, not to exceed 400 mg daily during follow-up, for easing symptoms in the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Data to assess proper use were collected through use of a medical questionnaire and patient form. Data pertaining to indication was collected by open-field to allow physicians to precisely indicate the reason for prescription. Recorded indications were then analyzed by two medical experts (an independent expert and a member of the Scientific Community) to assess proper use or misuse.

  • Indications for Which Arcoxia® and Celebrex® Were Prescribed [ Time Frame: At study entry ] [ Designated as safety issue: No ]
    The reasons (indications) for prescribing of Arcoxia® or Celebrex® were collected in open-field forms by the Investigator; category assignment (i.e, re-codification) of verbatim entries was conducted by a group of medical experts under the guidance approved by the MA. This endpoint gives the number of participants treated per indication.

  • Dosage of Arcoxia® and Celebrex® at Initiation [ Time Frame: At study entry ] [ Designated as safety issue: No ]
    Dosage at initiation of treatment with Arcoxia® or Celebrex® was identified. MA compliant dosage at initiation corresponds to a (starting) dose of 30 mg daily for Arcoxia® or a (starting) dose of 200 mg daily for Celebrex®. The dose for initiation was calculated by multiplying the number of doses per day with the dose level (total daily dose) as noted in the prescription record.

  • Mean Dosage of Arcoxia® and Celebrex® During Treatment [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    The mean dosage of Arcoxia® and Celebrex® during treatment was determined. For participants who stopped treatment after their initial study visit, the maximum dose recorded at their final study visit was considered when calculating their mean dosage during treatment.

  • Number of Participants Requiring Dose Modification of Arcoxia® and Celebrex® [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Participants requiring modifications to their Arcoxia® or Celebrex® dose regimens during their on study treatment course were identified. Dose modifications were defined as an increase, decrease followed by increase, decrease, or increase followed by decrease in the participant's daily dose; all categorizations were exclusive. If the maximum dose at discontinuation of treatment was greater than that at initiation, the participant was considered as having had an increase in dose during treatment. Alternatively, if data obtained from a participant's prescription records showed a successive lowering of dosage, the participant was considered as having had a decrease in dose during treatment. Dosages at baseline were included in the dose modification determination for treatment renewal participants.

  • Duration of Prescription for Arcoxia® and Celebrex® at Enrollment [ Time Frame: Up to 3 months prior to study entry ] [ Designated as safety issue: No ]
    The mean duration of prescription at enrollment for participants treated with Arcoxia® and Celebrex® was determined using the participant's record.

  • Total Duration of Treatment With Arcoxia® and Celebrex® [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    The total duration of treatment (DoT) with Arcoxia® or Celebrex® was determined for populations that achieved end-of study and end-of-protocol or that were categorized as lost to follow-up. Participants enumerated as end-of-study had their treatment discontinued during the protocol-specified one year of follow-up. Participants enumerated as end-of-protocol were ongoing treatment at end of the protocol-specified one year of follow-up. Participants categorized as lost to follow-up had no follow-up visit where a determination of discontinuation from treatment could be made.

  • Maximum Dosage Prescribed During Treatment With Arcoxia® and Celebrex® [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Mean maximum dosage prescribed during follow-up in participants treated with Arcoxia® or Celebrex®. Dosage is expressed as total daily dose.

  • Reasons for Discontinuation of Treatment With Arcoxia® and Celebrex® [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    The individual reasons for discontinuation of treatment with Arcoxia® or Celebrex® were identified over the course of study through either physician selection from a pre-determined list or verbatim entry by the physician with subsequent re-codification by Sponsor.

  • Type of Arcoxia® and Celebrex® Use [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    The type of Arcoxia® or Celebrex® use during the study was classified as continuous (without interruption >7 days) or intermittent (with interruption >7 days) by the Investigating Physician at time of treatment discontinuation.

  • Type of Arcoxia® and Celebrex® Use According to Duration of Treatment [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Use of selective cyclooxygenase-2 (COX-2) inhibitors (Arcoxia® and Celebrex®) as assessed by the Investigating Physician at time of treatment discontinuation was correlated to the overall duration of treatment experienced by the participant (i.e., intermittent or continuous selective COX-2 inhibitor use vs. total participant time on treatment). Type of use was classified as continuous (without interruption >7 days) or intermittent (with interruption >7 days). Four successive treatment intervals were assessed in this endpoint: 1) Up to thirty days of treatment 2) From one to three months of treatment 3) From three months to one year of treatment and 4) More than one year of treatment.


Secondary Outcome Measures:
  • Mean Body Mass Index (BMI) at Study Entry in Participants Treated With Arcoxia® and Celebrex® [ Time Frame: At study entry (baseline) ] [ Designated as safety issue: No ]
    Participants' BMI was assessed at study entry by the Investigating Physician. BMI is calculated as the participant's weight in kilograms (kg) divided by height in meters squared. BMI under 18.5 is commonly considered underweight; within the range (18.5 to 25) as normal weight; within the range (25 to 30) as overweight; and over 30 as obese.

  • Mean Systolic and Diastolic Blood Pressure (BP) at Study Entry in Participants Treated With Arcoxia® and Celebrex® [ Time Frame: At study entry (baseline) ] [ Designated as safety issue: No ]
    Mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) were assessed at study entry by the Investigating Physician. Definition of controlled BP: SBP <140 mmHg and DBP <90 mmHg. Definition of uncontrolled BP: SBP ≥140 mmHg and/or DBP ≥90 mmHg.

  • Blood Pressure at Study Entry in Participants Treated With Arcoxia® and Celebrex® [ Time Frame: At study entry (baseline) ] [ Designated as safety issue: No ]
    Participants' BP (SBP/DBP) was assessed at study entry by the Investigating Physician. Definition of controlled BP: SBP <140 mmHg and DBP <90 mmHg. Definition of uncontrolled BP: SBP ≥140 mmHg and/or DBP ≥90 mmHg.

  • Medical History of Participants Treated With Arcoxia® and Celebrex® [ Time Frame: At study entry ] [ Designated as safety issue: No ]
    Relevant medical history of participants treated with Arcoxia® or Celebrex® was recorded by the Investigating Physician.

  • Co-morbidities in Participants Treated With Arcoxia® and Celebrex® [ Time Frame: At study entry ] [ Designated as safety issue: No ]
    Associated co-morbidities at study entry (baseline) in participants treated with Arcoxia® or Celebrex® were recorded by the Investigating Physician. CHF/IHD/PAD = Congestive heart failure/Ischemic heart disease/Peripheral artery disease

  • Significant Past Treatments Prior to Initiating Treatment With Arcoxia® or Celebrex® [ Time Frame: At study entry ] [ Designated as safety issue: No ]
    'Significant' treatments that preceded the use of selective COX-2 inhibitors (Arcoxia® or Celebrex®) were identified using a closed-ended (yes/ no/ do not know) questionnaire. Significant is defined as associated with a chronic disease or having a potential link with participant's current use of a selective COX-2 inhibitors (Arcoxia® or Celebrex®). ARBs = Angiotensin 2 receptor blockers. ACEIs = Angiotensin-converting enzyme inhibitors. SSRIs = Selective serotonin reuptake Inhibitors. PAIs = Platelet aggregation inhibitors.

  • Medications Co-Prescribed at Study Entry in Participants Treated With Arcoxia® and Celebrex® [ Time Frame: At study entry ] [ Designated as safety issue: No ]
    Concomitant medications prescribed to participants treated with Arcoxia® and Celebrex® were collected via the physician prescription note at time of participant's study entry. NSAIDS = Non-steroidal anti-inflammatory agents.

  • Medications Co-Prescribed Over the Course of Follow-up With Arcoxia® and Celebrex® [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Concomitant medications prescribed during the course of follow-up to participants treated with Arcoxia® and Celebrex® were extracted from participants' medical records. NSAIDS = Non-steroidal anti-inflammatory agents.

  • Number of Participants Treated With Other Agents Prior to Initiation of Arcoxia® and Celebrex® [ Time Frame: Up to 3 months prior to study entry ] [ Designated as safety issue: No ]
    Other prescribed agents for the same study indication within 3 months preceding the decision to initiate treatment with selective COX-2 inhibitors (Arcoxia® or Celebrex®) were determined using the participant's medical record. NSAIDS = Non-steroidal inflammatory agents.

  • Number of Participants Switching to Another Treatment With the Same Reason for Prescription [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Participants who switched to another NSAID or other therapy for the same reason for prescription upon discontinuation of treatment with Arcoxia® or Celebrex® were determined.

  • Number of Participants With Contraindications for Use of Arcoxia® [ Time Frame: At study entry ] [ Designated as safety issue: Yes ]
    Participants noted with contraindications for use of Arcoxia® according to the MA during initiation of treatment are described. CHF = congestive heart failure. HA = hepatic impairment. IBD = inflammatory bowel disease. IHD = ischemic heart disease. PAD = peripheral artery disease.

  • Number of Participants Who Experienced at Least One Adverse Event [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
    An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.

  • Number of Participants Who Discontinued Study Drug Due to an Adverse Event [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
    Discontinuation/withdrawal of study treatment due to an adverse event was performed at the discretion of the investigator or the Sponsor for safety concerns. An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.


Enrollment: 547
Study Start Date: June 2012
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group Arcoxia®
Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
Drug: etorocoxib
Administered as 30 mg or 60 mg oral film-coated tablets
Other Name: Arcoxia®
Group Celebrex®
Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
Drug: celecoxib
Administered as 100 mg or 200 mg oral hard capsules
Other Name: Celebrex®

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants spontaneously consulting a general practitioner or rheumatologist and having agreed to take part in this study.
Criteria

Inclusion Criteria:

  • Treatment-naive, discontinued the previous treatment course of etoricoxib or celecoxib at least 3 months previously or currently receiving continuous treatment with oral etoricoxib or celecoxib
  • Consent to take part in the study
  • Included in his/her physician's client base for at least 1 year

Exclusion Criteria:

  • Unable to receive follow-up over a year
  • Included in an interventional 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: NCT01572675

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01572675     History of Changes
Other Study ID Numbers: 0663-148 
Study First Received: February 3, 2012
Results First Received: April 15, 2016
Last Updated: April 15, 2016
Health Authority: France: ANSM - French Health Products Safety Agency

Keywords provided by Merck Sharp & Dohme Corp.:
Pharmacoepidemiological
Longitudinal
Observational

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Celecoxib
Etoricoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 21, 2016