Arthritis, RheumatoidPhase 3NCT01208181

A Two-Part, 12-Week Study of Etoricoxib as a Treatment for Rheumatoid Arthritis (RA) (MK-0663-107)

A Phase 3 study testing Etoricoxib 60 mg and Etoricoxib 90 mg in people with Arthritis, Rheumatoid, run by Organon and Co.

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: Arthritis, Rheumatoid
What is being tested?: Etoricoxib 60 mg and Etoricoxib 90 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,404 participants
Where: No sites listed yet
Study dates: 27 Sep 2010to 29 Jul 2014
Phase: Phase 3
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

Who may be able to join

Is male or female ≥ 18 years of age in general good health (other than RA)
Has an American College of Rheumatology Rheumatoid Clinical Response Criteria (ACR) Functional Class I, II, or III
Has a diagnosis of RA at least 6 months ago and was at least 16 years of age when diagnosed
Has a history of positive therapeutic benefit with nonsteroidal anti-inflammatory drugs (NSAIDs) and is taking an NSAID on a regular basis and at a therapeutic dose level and is not anticipated to undergo a change during the study

Who cannot join

Has a concurrent medical/arthritic disease that could confound or interfere with evaluation of efficacy
Has a history of gastric or biliary surgery (including gastric bypass surgery) or small intestine surgery that causes clinical malabsorption
Has an active peptic (gastric or duodenal) ulcer or history of inflammatory bowel disease
Has a confirmed medical diagnosis of ischemic heart disease, cerebrovascular disease, or peripheral artery occlusive disease
Class II-IV congestive heart failure
Has uncontrolled hypertension (systolic >160 mm Hg or diastolic > 90 mm Hg) at Visit 1 or Visit 2

Show all 16Show fewer

Has a clinical diagnosis of hepatic insufficiency defined as Child-Pugh score ≥5
Has estimated glomerular filtration rate ≤30 mL/min
Has a history of neoplastic disease within 5 years (exceptions: basal cell carcinoma or carcinoma in situ of the cervix)
Is allergic to etoricoxib; history of a significant clinical or laboratory adverse experience associated with etoricoxib; hypersensitivity to aspirin or NSAIDs; or allergy to acetaminophen/paracetamol
Has a personal or family history of an inherited or acquired bleeding disorder
Requires oral corticosteroid therapy in excess of the equivalent of 10 mg daily of prednisone and/or have not been on a stable dose for at least 4 weeks prior to Visit 1 and/or whose dose is not expected to remain stable during the study
Treated with B-cell depleting therapies within the past 6 months or anticipate this treatment during this trial
Is a recreational or illicit drug use, or history within 5 years of drug or alcohol abuse/dependence;
Is morbidly obese (defined as body mass index ≥40 kg/m^2)
Is pregnant or breast feeding

About this study

Official title: A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients With Rheumatoid Arthritis

This is a 2-part (6 weeks duration for each part), randomized, double-blind, placebo-controlled study in participants with rheumatoid arthritis. The hypothesis is that etoricoxib (60 mg and 90 mg) administration will demonstrate superior efficacy compared to placebo after 6 weeks of treatment, as measured by the greater mean improvement from baseline in the Disease Activity Score C-Reactive Protein (DAS-28 CRP), and by the greater mean improvement in Patient Global Assessment of Pain (PGAP) from baseline over 6 weeks of treatment. Additionally, the added benefit of increasing the dose of etoricoxib from 60 mg to 90 mg will be assessed in the second part of the study.

Conditions: Arthritis, Rheumatoid
Being tested: Etoricoxib 60 mg, Etoricoxib 90 mg, Placebo to Etoricoxib 60 mg, Placebo to Etoricoxib 90 mg
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Etoricoxib 60 mgDrug
Also called MK-0663
One tablet orally once daily for 6 weeks.
Etoricoxib 90 mgDrug
Also called MK-0663
One tablet orally once daily for 6 weeks.
Placebo to Etoricoxib 60 mgDrug
One tablet orally once daily for 6 weeks.
Placebo to Etoricoxib 90 mgDrug
One tablet orally once daily for 6 weeks

Study groups in NCT01208181
Study group	Role	What they receive
Etoricoxib 60 mg/Etoricoxib 60 mg	Experimental	The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence will receive etoricoxib 60 mg tablets administered orally once daily for 6 weeks in Part 1 and Part 2 of the study. Receives: Drug: Etoricoxib 60 mg; Drug: Placebo to Etoricoxib 60 mg
Etoricoxib 60 mg/Etoricoxib 90 mg	Experimental	The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib 60 mg tablets administered orally once daily for 6 weeks in Part 1 and etoricoxib 90 mg tablets administered orally once daily for 6 weeks in Part 2 of the study. Receives: Drug: Etoricoxib 60 mg; Drug: Placebo to Etoricoxib 60 mg
Etoricoxib 90 mg	Experimental	The etoricoxib 90 mg treatment sequence will receive etoricoxib 90 mg tablets administered orally once daily for 6 weeks in Part 1 and will not participate in Part 2 of the study. Receives: Drug: Etoricoxib 90 mg; Drug: Placebo to Etoricoxib 90 mg
Placebo	Placebo comparator	The placebo treatment sequence will receive matching placebo to etoricoxib tablets administered orally once daily for 6 weeks in Part 1 and will not participate in Part 2 of the study. Receives: Drug: Placebo to Etoricoxib 60 mg; Drug: Placebo to Etoricoxib 90 mg

What is being measured

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

Time-Weighted Average Change From Baseline in DAS28-CRP in Part 1 (Etoricoxib vs. Placebo)
Disease Activity Score Using C-Reactive Protein [DAS28-CRP] (0 - 10 Range). The DAS28-CRP index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity, and C-reactive protein (CRP). For each observation (Baseline, Week 2, 4, 6, 10, 12), components were combined into a single DAS28-CRP score using the following algorithm: 0.56*square root (sqrt) (tender joint count [28])+0.28*sqrt(swollen joint count [28] )+0.36* ln(crp+1) + 0.014* Patient Global Assessment of Disease Activity + 0.96. The primary objectives of the study compared the efficacy of etoricoxib (90 mg, 60 mg) to placebo in Part 1 of this study so data for only these 3 arms are displayed.
Measured: Baseline and Week 6
Time-Weighted Average Change From Baseline in Patient Global Assessment of Pain in Part 1 (Etoricoxib vs. Placebo)
A participant overall assessment of pain on a visual analog scale (VAS) was assessed with a question concerning the amount of pain due to arthritis during the past 48 hours. Pain was assessed on an 100 mm VAS scale with a left-hand marker "no pain" (0 mm) or right-hand marker "extreme pain" (100 mm). The primary objectives of the study compared the efficacy of etoricoxib (90 mg, 60 mg) to placebo in Part 1 of this study so data for only these 3 arms are displayed.
Measured: Baseline and Week 6
Percentage of Participants Who Experienced at Least One Adverse Event (AE)
An AE 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.
Measured: Up to 112 days
Percentage of Participants Who Discontinued Study Drug Due to an AE
An AE 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.
Measured: Up to Week 12

Secondary outcomes (3)

Time-Weighted Average Change From Baseline in DAS28-CRP in Part 1 (Etoricoxib 90 mg vs. Etoricoxib 60 mg)
Disease Activity Score Using C-Reactive Protein [DAS28-CRP] (0 - 10 Range). The DAS28-CRP index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity, and C-reactive protein (CRP). For each observation (Baseline, Week 2, 4, 6, 10, 12), components were combined into a single DAS28-CRP score using the following algorithm: 0.56*square root (sqrt) (tender joint count [28])+0.28*sqrt(swollen joint count [28] )+0.36* ln(crp+1) + 0.014* Patient Global Assessment of Disease Activity + 0.96. The key secondary objectives compared the relative efficacy between etoricoxib 90 mg and 60 mg in Part 1 of this study so data for only these 2 arms are displayed.
Measured: Baseline and Week 6
Time-Weighted Average Change From Baseline in Patient Global Assessment of Pain in Part 1 (Etoricoxib 90 mg vs. Etoricoxib 60 mg)
A participant overall assessment of pain on a visual analog scale (VAS) was assessed with a question concerning the amount of pain due to arthritis during the past 48 hours. Pain was assessed on an 100 mm VAS scale with a left-hand marker "no pain" (0 mm) or right-hand marker "extreme pain" (100 mm). The key secondary objectives compared the relative efficacy between etoricoxib 90 mg and 60 mg in Part 1 of this study so data for only these 2 arms are displayed.
Measured: Baseline and Week 6
Average Change From Week 6 in Patient Global Assessment of Pain Over Weeks 10 and 12 in Part 2 Among Pain Inadequate Responders From Part 1
A participant overall assessment of pain on a visual analog scale (VAS) was assessed with a question concerning the amount of pain due to arthritis during the past 48 hours. Pain was assessed on an 100 mm VAS scale with a left-hand marker "no pain" (0 mm) or right-hand marker "extreme pain" (100 mm). In those participants who were considered inadequate responders to etoricoxib 60 mg in Part 1 (defined as a participant with <50% improvement from baseline in PGAP [VAS] at Week 6), the incremental benefit of increasing the etoricoxib dose from 60 mg (in Part 1) to 90 mg (in Part 2) compared to remaining on 60 mg in Part 2 was evaluated via average change from Week 6 over Weeks 10 and 12 in Patient Global Assessment of Pain score. Therefore, data for only these 2 arms are displayed.
Measured: Week 6 and Week 10 to Week 12

Timeline

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

27 Sep 201029 Jul 2014

First posted23 Sep 2010 (estimated)
Study start27 Sep 2010
Primary completion9 Jun 2014
Study completion29 Jul 2014

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
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: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 1,404 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01208181
Sponsor's protocol ID: 0663-107
Other IDs: 2010-019871-31
Status last verified: Feb 2022
First submitted: 22 Sep 2010
Last updated: 18 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Bickham K, Kivitz AJ, Mehta A, Frontera N, Shah S, Stryszak P, Popmihajlov Z, Peloso PM. Evaluation of two doses of etoricoxib, a COX-2 selective non-steroidal anti-inflammatory drug (NSAID), in the treatment of Rheumatoid Arthritis in a double-blind, randomized controlled trial. BMC Musculoskelet Disord. 2016 Aug 8;17:331. doi: 10.1186/s12891-016-1170-0.
PubMed 27502582

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?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients With Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT01208181
Acronym / sponsor ID: 0663-107
Conditions: Arthritis, Rheumatoid
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,404 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: 27 Sep 2010 (actual)
Primary completion: 9 Jun 2014 (actual)
Study completion: 29 Jul 2014 (actual)
First posted: 23 Sep 2010 (estimated)
Results: Posted 21 May 2015

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Etoricoxib 60 mg/Etoricoxib 60 mg	Experimental	Drug: Etoricoxib 60 mg, Drug: Placebo to Etoricoxib 60 mgThe etoricoxib 60 mg/etoricoxib 60 mg treatment sequence will receive etoricoxib 60 mg tablets administered orally once daily for 6 weeks in Part 1 and Part 2 of the study.
Etoricoxib 60 mg/Etoricoxib 90 mg	Experimental	Drug: Etoricoxib 60 mg, Drug: Placebo to Etoricoxib 60 mgThe etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib 60 mg tablets administered orally once daily for 6 weeks in Part 1 and etoricoxib 90 mg tablets administered orally once daily for 6 weeks in Part 2 of the study.
Etoricoxib 90 mg	Experimental	Drug: Etoricoxib 90 mg, Drug: Placebo to Etoricoxib 90 mgThe etoricoxib 90 mg treatment sequence will receive etoricoxib 90 mg tablets administered orally once daily for 6 weeks in Part 1 and will not participate in Part 2 of the study.
Placebo	Placebo comparator	Drug: Placebo to Etoricoxib 60 mg, Drug: Placebo to Etoricoxib 90 mgThe placebo treatment sequence will receive matching placebo to etoricoxib tablets administered orally once daily for 6 weeks in Part 1 and will not participate in Part 2 of the study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Is male or female ≥ 18 years of age in general good health (other than RA)
Has an American College of Rheumatology Rheumatoid Clinical Response Criteria (ACR) Functional Class I, II, or III
Has a diagnosis of RA at least 6 months ago and was at least 16 years of age when diagnosed
Has a history of positive therapeutic benefit with nonsteroidal anti-inflammatory drugs (NSAIDs) and is taking an NSAID on a regular basis and at a therapeutic dose level and is not anticipated to undergo a change during the study

Key exclusion criteria (16 listed)

Has a concurrent medical/arthritic disease that could confound or interfere with evaluation of efficacy
Has a history of gastric or biliary surgery (including gastric bypass surgery) or small intestine surgery that causes clinical malabsorption
Has an active peptic (gastric or duodenal) ulcer or history of inflammatory bowel disease
Has a confirmed medical diagnosis of ischemic heart disease, cerebrovascular disease, or peripheral artery occlusive disease
Class II-IV congestive heart failure

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

Interventions

Intervention	Type	Arms
Etoricoxib 60 mgAlso: MK-0663One tablet orally once daily for 6 weeks.	Drug	Etoricoxib 60 mg/Etoricoxib 60 mg, Etoricoxib 60 mg/Etoricoxib 90 mg
Etoricoxib 90 mgAlso: MK-0663One tablet orally once daily for 6 weeks.	Drug	Etoricoxib 90 mg
Placebo to Etoricoxib 60 mgOne tablet orally once daily for 6 weeks.	Drug	Etoricoxib 60 mg/Etoricoxib 60 mg, Etoricoxib 60 mg/Etoricoxib 90 mg, Placebo
Placebo to Etoricoxib 90 mgOne tablet orally once daily for 6 weeks	Drug	Etoricoxib 90 mg, Placebo

Primary outcome

Time-Weighted Average Change From Baseline in DAS28-CRP in Part 1 (Etoricoxib vs. Placebo)
Time frame: Baseline and Week 6
Disease Activity Score Using C-Reactive Protein [DAS28-CRP] (0 - 10 Range). The DAS28-CRP index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity, and C-reactive protein (CRP). For each observation (Baseline, Week 2, 4, 6, 10, 12), components were combined into a single DAS28-CRP score using the following algorithm: 0.56*square root (sqrt) (tender joint count [28])+0.28*sqrt(swollen joint count [28] )+0.36* ln(crp+1) + 0.014* Patient Global Assessment of Disease Activity + 0.96. The primary objectives of the study compared the efficacy of etoricoxib (90 mg, 60 mg) to placebo in Part 1 of this study so data for only these 3 arms are displayed.
Time-Weighted Average Change From Baseline in Patient Global Assessment of Pain in Part 1 (Etoricoxib vs. Placebo)
Time frame: Baseline and Week 6
A participant overall assessment of pain on a visual analog scale (VAS) was assessed with a question concerning the amount of pain due to arthritis during the past 48 hours. Pain was assessed on an 100 mm VAS scale with a left-hand marker "no pain" (0 mm) or right-hand marker "extreme pain" (100 mm). The primary objectives of the study compared the efficacy of etoricoxib (90 mg, 60 mg) to placebo in Part 1 of this study so data for only these 3 arms are displayed.
Percentage of Participants Who Experienced at Least One Adverse Event (AE)
Time frame: Up to 112 days
An AE 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.
Percentage of Participants Who Discontinued Study Drug Due to an AE
Time frame: Up to Week 12
An AE 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.

3 secondary outcomes

Time-Weighted Average Change From Baseline in DAS28-CRP in Part 1 (Etoricoxib 90 mg vs. Etoricoxib 60 mg)
Time frame: Baseline and Week 6
Time-Weighted Average Change From Baseline in Patient Global Assessment of Pain in Part 1 (Etoricoxib 90 mg vs. Etoricoxib 60 mg)
Time frame: Baseline and Week 6
Average Change From Week 6 in Patient Global Assessment of Pain Over Weeks 10 and 12 in Part 2 Among Pain Inadequate Responders From Part 1
Time frame: Week 6 and Week 10 to Week 12

Results and safety

Results posted to the registry on 21 May 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Etoricoxib 60 mg	818	719
Etoricoxib 90 mg	468	413
Etoricoxib 60 mg/Etoricoxib 60 mg	0	0
Etoricoxib 60/Etoricoxib 90mg	0	0
Placebo	118	96

Primary outcome: Time-Weighted Average Change From Baseline in DAS28-CRP in Part 1 (Etoricoxib vs. Placebo)

Time frame: Baseline and Week 6. Least squares mean (95% Confidence Interval). Unit: Scores on a scale

Measure	Etoricoxib 60 mg n = 732	Etoricoxib 90 mg n = 426	Placebo n = 103
Value	-1.39 (-1.48 to -1.30)	-1.37 (-1.48 to -1.26)	-1.10 (-1.29 to -0.90)

Etoricoxib 60 mg vs Placebo: Difference in least squares mean: -0.29 (95% CI -0.49 to -0.09), p = 0.004, Tukey-Ciminera-Heysetrend test
Etoricoxib 90 mg vs Placebo: Difference in least squares mean: -0.27 (95% CI -0.48 to -0.06), p = 0.034, Tukey-Ciminera-Heysetrend test

Population analysed: The modified intention-to-treat (mITT) population in Part 1 consisted of all randomized participants receiving at least 1 dose of study medication, had baseline data for the analysis endpoint, and least one post-randomization measurement for the analysis endpoint that was collected within 3 days after the last dose of study medication.

Primary outcome: Time-Weighted Average Change From Baseline in Patient Global Assessment of Pain in Part 1 (Etoricoxib vs. Placebo)

Time frame: Baseline and Week 6. Least squares mean (95% Confidence Interval). Unit: Scores on a scale

Measure	Etoricoxib 60 mg n = 751	Etoricoxib 90 mg n = 430	Placebo n = 108
Value	-28.25 (-30.05 to -26.44)	-30.96 (-33.13 to -28.79)	-20.26 (-24.04 to -16.48)

Etoricoxib 60 mg vs Placebo: Difference in least squares mean: -7.99 (95% CI -11.85 to -4.13), p <0.001, Tukey-Ciminera-Heyse trend test
Etoricoxib 90 mg vs Placebo: Difference in least squares mean: -10.70 (95% CI -14.74 to -6.66), p <0.001, Tukey-Ciminera-Heyse trend test

Population analysed: The mITT population in Part 1 consisted of all randomized participants receiving at least 1 dose of study medication, had baseline data for the analysis endpoint, and least one post-randomization measurement for the analysis endpoint that was collected within 3 days after the last dose of study medication.

Primary outcome: Percentage of Participants Who Experienced at Least One Adverse Event (AE)

Time frame: Up to 112 days. Number. Unit: Percentage of participants

Measure	Etoricoxib 60 mg - Part 1 n = 819	Etoricoxib 90 mg - Part 1 n = 467	Etoricoxib 60mg/Etoricoxib 60mg - Part 1/2 n = 350	Etoricoxib 60mg/Etoricoxib 90mg - Part 1/2 n = 363	Placebo - Part 1 n = 118
Value	30.3	36.0	19.1	24.5	25.4

Population analysed: All Subjects as Treated (ASaT) population, defined as all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data using the ASaT population.

Primary outcome: Percentage of Participants Who Discontinued Study Drug Due to an AE

Time frame: Up to Week 12. Number. Unit: Percentage of participants

Measure	Etoricoxib 60 mg - Part 1 n = 819	Etoricoxib 90 mg - Part 1 n = 467	Etoricoxib 60mg/Etoricoxib 60mg - Part 1/2 n = 350	Etoricoxib 60mg/Etoricoxib 90mg - Part 1/2 n = 363	Placebo - Part 1 n = 118
Value	3.3	5.1	1.4	1.9	3.4

Population analysed: ASaT population defined as all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data using the ASaT population.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 112 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Etoricoxib 60 mg - Part 1	7 of 819 (0.9%)	25 of 819 (3.1%)	Not reported
Etoricoxib 90 mg - Part 1	2 of 467 (0.4%)	17 of 467 (3.6%)	Not reported
Etoricoxib 60mg/Etoricoxib 60mg - Part 1/2	4 of 350 (1.1%)	6 of 350 (1.7%)	Not reported
Etoricoxib 60mg/Etoricoxib 90mg - Part 1/2	5 of 363 (1.4%)	6 of 363 (1.7%)	Not reported
Placebo - Part 1	0 of 118 (0%)	6 of 118 (5.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27502582Bickham K, Kivitz AJ, Mehta A, Frontera N, Shah S, Stryszak P, Popmihajlov Z, Peloso PM. Evaluation of two doses of etoricoxib, a COX-2 selective non-steroidal anti-inflammatory drug (NSAID), in the treatment of Rheumatoid Arthritis in a double-blind, randomized controlled trial. BMC Musculoskelet Disord. 2016 Aug 8;17:331. doi: 10.1186/s12891-016-1170-0.
Individual participant dataSharing planned: No

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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.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Etoricoxib 60 mg and Etoricoxib 90 mg in people with Arthritis, Rheumatoid, run by Organon and Co.

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

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. 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 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 May 2015). 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?

Time-Weighted Average Change From Baseline in DAS28-CRP in Part 1 (Etoricoxib vs. Placebo) (time frame: Baseline and Week 6). The study lists 4 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 NCT01208181, which also lists 1 linked publication.

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 18 Jun 2024.