CompletedNCT00264147Updated Feb 9, 2022Results posted

Rheumatoid Arthritis Dose Ranging Study (0663-086)(COMPLETED)

A Phase 2 interventional study of etoricoxib and etoricoxib in Rheumatoid Arthritis, sponsored by Organon and Co. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-09.

Sponsored by Organon and Co · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 761
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

To assess the clinically active dose range of study medication in the treatment of patients with rheumatoid arthritis.

Conditions studied

Rheumatoid Arthritis

Browse trials for

Arthritis, Rheumatoid 2,962

Keywords

Arcoxia

In context

Arthritis, Rheumatoid

2,962 studies on the registry are indexed under Arthritis, Rheumatoid; 396 are open to participants now.

This study's enrollment of 761 is above the median of 94 across 2,027 interventional studies indexed under Arthritis, Rheumatoid.

Browse Arthritis, Rheumatoid studies →

Lead sponsor

Organon and Co is the lead sponsor of 505 studies on the registry; none are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.

Browse Organon & Co. studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patient with diagnosed rheumatoid arthritis (RA) for at least 6 months prior who is otherwise judged to be in general good health and who is currently taking nonsteroidal anti-inflammatory drugs (NSAIDS) to treat his/her RA symptoms
Patient will need to stop taking these medications in order to participate, but can continue taking his/her other anti-rheumatic medications as long as they have been stable for certain periods of time

Exclusion criteria

Exclusion Criteria:

Patients with a disease or medical condition(s) that could worsen or interfere with the evaluation of the effectiveness of study medication are not allowed to participate

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 761 participants (actual)

Study arms

Experimental
Period I: 1
etoricoxib
Drug: etoricoxib
Experimental
Period I: 2
etoricoxib
Drug: etoricoxib
Experimental
Period I: 3
etoricoxib
Drug: etoricoxib
Experimental
Period I: 4
etoricoxib
Drug: etoricoxib
Placebo comparator
Period I: 5
Placebo
Drug: Comparator: placebo
Experimental
Period II: 1
etoricoxib
Drug: etoricoxib
Active comparator
Period II: 2
diclofenac
Drug: Comparator: diclofenac

Interventions

Drugetoricoxib
Period I: Arm 1: etoricoxib 10 mg tablet once daily. 12 weeks of treatment.
Drugetoricoxib
Period I: Arm 2: etoricoxib 30 mg tablet once daily. 12 weeks of treatment.
Drugetoricoxib
Period I: Arm 3: etoricoxib 60 mg tablet once daily. 12 weeks of treatment.
Drugetoricoxib
Period I: Arm 4: etoricoxib 90 mg tablet once daily. 12 weeks of treatment.
DrugComparator: placebo
Period I: Arm 5: Pbo tablet once daily. 12 weeks of treatment.
Drugetoricoxib
Period II: Arm 1: etoricoxib 90 mg tablet once daily. 12 weeks of treatment.
DrugComparator: diclofenac
Period II: Arm 2: diclofenac 75 mg tablet twice daily. 12 weeks of treatment.

What researchers measure

Primary outcomes

Proportion of Patients Who Met the ACR20 Responder Index Criteria
Proportion of Patients Who Met the American College of Rheumatology Response Index (20%) Criteria (ACR20) (Based on the Time-Weighted Average Responses of the 12-Week Treatment I Period and Completed the Treatment I Period) (All Patients-Treated Population)
Time frame: 12 weeks

Secondary outcomes

Tender Joint Count (Out of 68 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population)
Time frame: Time-weighted average change from baseline across Weeks 2, 7, and 12
Swollen Joint Count (Out of 66 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population)
Time frame: Time-weighted average change from baseline across Weeks 2, 7, and 12
Patient Global Assessment of Disease Activity (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population)
0-mm indicates very well, 100-mm indicates very poor.
Time frame: Time-weighted average change from baseline across Weeks 2, 7, and 12
Investigator Global Assessment of Disease Activity (0- to 4-Likert Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population)
0 indicates very well, 4 indicates very poor.
Time frame: Time-weighted average change from baseline across Weeks 2, 7, and 12
Patient Global Assessment of Pain (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population)
0-mm indicates very well, 100-mm indicates very poor.
Time frame: Time-weighted average change from baseline across Weeks 2, 7, and 12

Results

Posted Jul 7, 2009

Participant flow

90 multicenter rheumatologists: US (71), Canada (14), Colombia (3), Switzerland (2), recruited 761 study patients from their patient pool and through advertising. First Patient In 04-Jan-2006, Last Patient Last Visit 26-Mar-2008.

Treatment I Period

Participant flow — Treatment I Period
Milestone	Placebo	Etoricoxib 10 mg	Etoricoxib 30 mg	Etoricoxib 60 mg	Etoricoxib 90 mg
Started	161	154	151	140	155
Completed	63	71	74	68	99
Not completed	98	83	77	72	56
Withdrew: Adverse event	3	6	3	5	7
Withdrew: Laboratory adverse event	0	0	0	1	0
Withdrew: Lack of efficacy	6	2	8	0	1
Withdrew: Lost to follow-up	1	0	0	1	1
Withdrew: Protocol violation	2	2	0	0	0
Withdrew: Withdrawal by subject	2	0	0	2	2
Withdrew: Patient out of town for an extended time	0	1	0	0	0
Withdrew: Unblinded due to serious adverse event	0	0	1	0	0
Withdrew: Reassigned to treatment ii period	84	72	65	63	45

Treatment II Period

Participant flow — Treatment II Period
Milestone	Etoricoxib 90 mg	Diclofenac 150 mg (Treatment II)
Started	180	149
Completed	147	116
Not completed	33	33
Withdrew: Adverse event	9	9
Withdrew: Laboratory adverse event	0	1
Withdrew: Lack of efficacy	20	19
Withdrew: Lost to follow-up	1	1
Withdrew: Withdrawal by subject	3	2
Withdrew: Pre-scheduled total hip replacement	0	1

Outcome measures

PrimaryProportion of Patients Who Met the ACR20 Responder Index Criteria

Proportion of Patients Who Met the American College of Rheumatology Response Index (20%) Criteria (ACR20) (Based on the Time-Weighted Average Responses of the 12-Week Treatment I Period and Completed the Treatment I Period) (All Patients-Treated Population)

Time frame:: 12 weeks
Reported as:: Number · Proportion of Patients

Proportion of Patients Who Met the ACR20 Responder Index Criteria
Proportion of Patients	Placebo	Etoricoxib 10 mg	Etoricoxib 30 mg	Etoricoxib 60 mg	Etoricoxib 90 mg
Proportion of Patients Who Met the ACR20 Responder Index Criteria	28.57	35.06	37.75	38.57	47.10

Statistical analysis

Placebo vs Etoricoxib 10 mg vs Etoricoxib 30 mg vs Etoricoxib 60 mg vs Etoricoxib 90 mg · Cochran-Armitage trend test · p = <0.001 (Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).)A step-down procedure and Abelson-Tukey scaling were used for the trend test.
Placebo vs Etoricoxib 10 mg vs Etoricoxib 30 mg vs Etoricoxib 60 mg · Cochran-Armitage trend test · p = 0.057 (Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).)A step-down procedure and Abelson-Tukey scaling were used for the trend test.
Placebo vs Etoricoxib 90 mg · Difference in percentage of patients: 18.53 · 95% CI 7.84 to 28.65CI based on the Wilson's score method.
Placebo vs Etoricoxib 60 mg · Difference in percentage of patients: 10.00 · 95% CI -0.66 to 20.46CI based on the Wilson's score method.
Placebo vs Etoricoxib 30 mg · Difference in percentage of patients: 9.18 · 95% CI -1.25 to 19.39CI based on the Wilson's score method.
Placebo vs Etoricoxib 10 mg · Difference in percentage of patients: 6.49 · 95% CI -3.76 to 16.61CI based on the Wilson's score method.

SecondaryTender Joint Count (Out of 68 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population)

Time frame:: Time-weighted average change from baseline across Weeks 2, 7, and 12
Reported as:: Mean · Tender Joint Count

Tender Joint Count (Out of 68 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population)
Tender Joint Count	Placebo	Etoricoxib 10 mg	Etoricoxib 30 mg	Etoricoxib 60 mg	Etoricoxib 90 mg
Tender Joint Count (Out of 68 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population)	-8.13 ± 9.55	-11.01 ± 13.07	-10.96 ± 11.00	-9.56 ± 11.85	-12.06 ± 11.22

Statistical analysis

Placebo vs Etoricoxib 10 mg vs Etoricoxib 30 mg vs Etoricoxib 60 mg vs Etoricoxib 90 mg · ANCOVA · p = 0.002 (Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).)Based on a trend test with a step-down procedure and Abelson-Tukey scaling.
Placebo vs Etoricoxib 10 mg vs Etoricoxib 30 mg vs Etoricoxib 60 mg · ANCOVA · p = 0.221 (Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).)Based on a trend test with a step-down procedure and Abelson-Tukey scaling.
Placebo vs Etoricoxib 90 mg · Mean difference (final values): -4.06 · 95% CI -6.44 to -1.68
Placebo vs Etoricoxib 60 mg · Mean difference (final values): -1.49 · 95% CI -3.91 to 0.93
Placebo vs Etoricoxib 30 mg · Mean difference (final values): -2.74 · 95% CI -5.13 to -0.35
Placebo vs Etoricoxib 10 mg · Mean difference (final values): -2.50 · 95% CI -4.88 to -0.12

SecondarySwollen Joint Count (Out of 66 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population)

Time frame:: Time-weighted average change from baseline across Weeks 2, 7, and 12
Reported as:: Mean · Swollen Joint Count

Swollen Joint Count (Out of 66 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population)
Swollen Joint Count	Placebo	Etoricoxib 10 mg	Etoricoxib 30 mg	Etoricoxib 60 mg	Etoricoxib 90 mg
Swollen Joint Count (Out of 66 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population)	-5.39 ± 7.34	-6.58 ± 8.11	-6.91 ± 7.27	-6.25 ± 7.48	-7.77 ± 7.17

Statistical analysis

Placebo vs Etoricoxib 10 mg vs Etoricoxib 30 mg vs Etoricoxib 60 mg vs Etoricoxib 90 mg · ANCOVA · p = 0.001 (Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).)Based on a trend test with a step-down procedure and Abelson-Tukey scaling.
Placebo vs Etoricoxib 10 mg vs Etoricoxib 30 mg vs Etoricoxib 60 mg · ANCOVA · p = 0.125 (Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).)Based on a trend test with a step-down procedure and Abelson-Tukey scaling.
Placebo vs Etoricoxib 90 mg · Mean difference (final values): -2.24 · 95% CI -3.64 to -0.84
Placebo vs Etoricoxib 60 mg · Mean difference (final values): -1.02 · 95% CI -2.44 to 0.41
Placebo vs Etoricoxib 30 mg · Mean difference (final values): -1.22 · 95% CI -2.63 to 0.18
Placebo vs Etoricoxib 10 mg · Mean difference (final values): -0.49 · 95% CI -1.89 to 0.91

SecondaryPatient Global Assessment of Disease Activity (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population)

0-mm indicates very well, 100-mm indicates very poor.

Time frame:: Time-weighted average change from baseline across Weeks 2, 7, and 12
Reported as:: Mean · Units on a Scale

Patient Global Assessment of Disease Activity (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population)
Units on a Scale	Placebo	Etoricoxib 10 mg	Etoricoxib 30 mg	Etoricoxib 60 mg	Etoricoxib 90 mg
Patient Global Assessment of Disease Activity (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population)	-12.32 ± 25.66	-19.90 ± 23.61	-21.12 ± 24.47	-21.49 ± 26.71	-25.75 ± 25.71

Statistical analysis

Placebo vs Etoricoxib 10 mg vs Etoricoxib 30 mg vs Etoricoxib 60 mg vs Etoricoxib 90 mg · ANCOVA · p = <0.001 (Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).)Based on a trend test with a step-down procedure and Abelson-Tukey scaling.
Placebo vs Etoricoxib 10 mg vs Etoricoxib 30 mg vs Etoricoxib 60 mg · ANCOVA · p = <0.001 (Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).)Based on a trend test with a step-down procedure and Abelson-Tukey scaling.
Placebo vs Etoricoxib 10 mg vs Etoricoxib 30 mg · ANCOVA · p = <0.001 (Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).)Based on a trend test with a step-down procedure and Abelson-Tukey scaling.
Placebo vs Etoricoxib 10 mg · ANCOVA · p = 0.023 (Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).)Based on a trend test with a step-down procedure and Abelson-Tukey scaling.
Placebo vs Etoricoxib 90 mg · Mean difference (final values): -14.16 · 95% CI -19.38 to -8.95
Placebo vs Etoricoxib 60 mg · Mean difference (final values): -9.21 · 95% CI -14.52 to -3.90
Placebo vs Etoricoxib 30 mg · Mean difference (final values): -8.87 · 95% CI -14.11 to -3.63
Placebo vs Etoricoxib 10 mg · Mean difference (final values): -6.05 · 95% CI -11.27 to -0.83

SecondaryInvestigator Global Assessment of Disease Activity (0- to 4-Likert Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population)

0 indicates very well, 4 indicates very poor.

Time frame:: Time-weighted average change from baseline across Weeks 2, 7, and 12
Reported as:: Mean · Units on a Scale

Investigator Global Assessment of Disease Activity (0- to 4-Likert Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population)
Units on a Scale	Placebo	Etoricoxib 10 mg	Etoricoxib 30 mg	Etoricoxib 60 mg	Etoricoxib 90 mg
Investigator Global Assessment of Disease Activity (0- to 4-Likert Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population)	-0.68 ± 1.06	-0.93 ± 0.94	-1.09 ± 1.01	-1.01 ± 0.94	-1.24 ± 0.94

Statistical analysis

Placebo vs Etoricoxib 10 mg vs Etoricoxib 30 mg vs Etoricoxib 60 mg vs Etoricoxib 90 mg · ANCOVA · p = <0.001 (Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).)Based on a trend test with a step-down procedure and Abelson-Tukey scaling.
Placebo vs Etoricoxib 10 mg vs Etoricoxib 30 mg vs Etoricoxib 60 mg · ANCOVA · p = <0.001 (Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).)Based on a trend test with a step-down procedure and Abelson-Tukey scaling.
Placebo vs Etoricoxib 10 mg vs Etoricoxib 30 mg · ANCOVA · p = <0.001 (Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).)Based on a trend test with a step-down procedure and Abelson-Tukey scaling.
Placebo vs Etoricoxib 10 mg · ANCOVA · p = 0.018 (Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).)Based on a trend test with a step-down procedure and Abelson-Tukey scaling.
Placebo vs Etoricoxib 90 mg · Mean difference (final values): -0.56 · 95% CI -0.77 to -0.35
Placebo vs Etoricoxib 60 mg · Mean difference (final values): -0.34 · 95% CI -0.55 to -0.13
Placebo vs Etoricoxib 30 mg · Mean difference (final values): -0.40 · 95% CI -0.61 to -0.19
Placebo vs Etoricoxib 10 mg · Mean difference (final values): -0.25 · 95% CI -0.46 to -0.04

SecondaryPatient Global Assessment of Pain (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population)

0-mm indicates very well, 100-mm indicates very poor.

Time frame:: Time-weighted average change from baseline across Weeks 2, 7, and 12
Reported as:: Mean · Units on a Scale

Patient Global Assessment of Pain (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population)
Units on a Scale	Placebo	Etoricoxib 10 mg	Etoricoxib 30 mg	Etoricoxib 60 mg	Etoricoxib 90 mg
Patient Global Assessment of Pain (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population)	-17.44 ± 23.42	-21.95 ± 22.87	-22.75 ± 23.86	-22.25 ± 26.58	-31.07 ± 24.18

Statistical analysis

Placebo vs Etoricoxib 10 mg vs Etoricoxib 30 mg vs Etoricoxib 60 mg vs Etoricoxib 90 mg · ANCOVA · p = <0.001 (Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).)Based on a trend test with a step-down procedure and Abelson-Tukey scaling.
Placebo vs Etoricoxib 10 mg vs Etoricoxib 30 mg vs Etoricoxib 60 mg · ANCOVA · p = 0.018 (Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).)Based on a trend test with a step-down procedure and Abelson-Tukey scaling.
Placebo vs Etoricoxib 10 mg vs Etoricoxib 30 mg · ANCOVA · p = 0.017 (Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).)Based on a trend test with a step-down procedure and Abelson-Tukey scaling.
Placebo vs Etoricoxib 10 mg · ANCOVA · p = 0.080 (Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).)Based on a trend test with a step-down procedure and Abelson-Tukey scaling.
Placebo vs Etoricoxib 90 mg · Mean difference (final values): -14.44 · 95% CI -19.62 to -9.26
Placebo vs Etoricoxib 60 mg · Mean difference (final values): -6.22 · 95% CI -11.52 to -0.92
Placebo vs Etoricoxib 30 mg · Mean difference (final values): -6.32 · 95% CI -11.53 to -1.12
Placebo vs Etoricoxib 10 mg · Mean difference (final values): -4.63 · 95% CI -9.81 to 0.55

Adverse events

Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo Treatment I Period	—	—	—
Etoricoxib 10 mg Treatment I Period	—	—	—
Etoricoxib 30 mg Treatment I Period	—	—	—
Etoricoxib 60 mg Treatment I Period	—	—	—
Etoricoxib 90 mg Treatment I Period	—	—	—
Etoricoxib 90 mg Treatment II Period	—	—	—
Diclofenac 150 mg Treatment II Period	—	—	—

Most frequent serious events

Showing 10 of 20

Most frequent serious events
Event	Placebo Treatment I Period	Etoricoxib 10 mg Treatment I Period	Etoricoxib 30 mg Treatment I Period	Etoricoxib 60 mg Treatment I Period	Etoricoxib 90 mg Treatment I Period	Etoricoxib 90 mg Treatment II Period	Diclofenac 150 mg Treatment II Period
Blood Creatinine IncreasedInvestigations	0/161	0/154	0/151	1/140	0/155	0/180	0/149
Accidental OverdoseInjury, poisoning and procedural complications	0/161	0/154	0/151	0/140	0/155	0/180	1/149
Malignant Melanoma In SituNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/161	0/154	0/151	0/140	0/155	0/180	1/149
Obsessive-Compulsive DisorderPsychiatric disorders	0/161	0/154	0/151	0/140	0/155	0/180	1/149
Coronary Artery DiseaseCardiac disorders	0/161	0/154	1/151	0/140	0/155	0/180	0/149
Myocardial InfarctionCardiac disorders	0/161	0/154	1/151	0/140	0/155	0/180	0/149
GastritisGastrointestinal disorders	0/161	0/154	1/151	0/140	0/155	0/180	0/149
Ileus ParalyticGastrointestinal disorders	0/161	0/154	1/151	0/140	0/155	0/180	0/149
ErysipelasInfections and infestations	0/161	0/154	1/151	0/140	0/155	0/180	0/149
Intervertebral Disc DisorderMusculoskeletal and connective tissue disorders	0/161	0/154	1/151	0/140	0/155	0/180	0/149

Most frequent other events

Showing 10 of 16

Most frequent other events
Event	Placebo Treatment I Period	Etoricoxib 10 mg Treatment I Period	Etoricoxib 30 mg Treatment I Period	Etoricoxib 60 mg Treatment I Period	Etoricoxib 90 mg Treatment I Period	Etoricoxib 90 mg Treatment II Period	Diclofenac 150 mg Treatment II Period
DiarrhoeaGastrointestinal disorders	3/161	4/154	2/151	8/140	7/155	4/180	6/149
HeadacheNervous system disorders	6/161	4/154	5/151	8/140	5/155	2/180	0/149
Upper Respiratory Tract InfectionInfections and infestations	4/161	0/154	4/151	1/140	2/155	4/180	7/149
HypertensionVascular disorders	0/161	2/154	3/151	6/140	5/155	6/180	1/149
DyspepsiaGastrointestinal disorders	5/161	2/154	1/151	3/140	6/155	2/180	4/149
DizzinessNervous system disorders	1/161	1/154	2/151	4/140	6/155	0/180	1/149
Oedema PeripheralGeneral disorders	1/161	2/154	2/151	5/140	1/155	6/180	4/149
ConstipationGastrointestinal disorders	0/161	1/154	5/151	3/140	2/155	1/180	1/149
Rheumatoid ArthritisMusculoskeletal and connective tissue disorders	3/161	1/154	3/151	4/140	2/155	1/180	3/149
NasopharyngitisInfections and infestations	1/161	4/154	0/151	1/140	4/155	2/180	1/149

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Placebo	Etoricoxib 10 mg	Etoricoxib 30 mg	Etoricoxib 60 mg	Etoricoxib 90 mg	Total
Mean	57.4 ± 11.80	58.7 ± 11.92	56.2 ± 11.17	57.7 ± 10.96	54.9 ± 12.54	57.0 ± 11.75

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo	Etoricoxib 10 mg	Etoricoxib 30 mg	Etoricoxib 60 mg	Etoricoxib 90 mg	Total
Female	136	117	126	112	122	613
Male	25	37	25	28	33	148

American Rheumatism Association Functional Class
American Rheumatism Association Functional Class(Participants)	Placebo	Etoricoxib 10 mg	Etoricoxib 30 mg	Etoricoxib 60 mg	Etoricoxib 90 mg	Total
Class I	44	49	49	41	38	221
Class II	102	83	83	73	98	439
Class III	15	22	19	26	19	101

Corticosteroid User
Corticosteroid User(Participants)	Placebo	Etoricoxib 10 mg	Etoricoxib 30 mg	Etoricoxib 60 mg	Etoricoxib 90 mg	Total
Yes	50	50	42	41	49	232
No	111	104	109	99	106	529

Disease Modifying Antirheumatic Drug User
Disease Modifying Antirheumatic Drug User(Participants)	Placebo	Etoricoxib 10 mg	Etoricoxib 30 mg	Etoricoxib 60 mg	Etoricoxib 90 mg	Total
Yes	133	129	122	114	131	629
No	28	25	29	26	24	132

Disease Modifying Antirheumatic Drug or Corticosteroid User
Disease Modifying Antirheumatic Drug or Corticosteroid User(Participants)	Placebo	Etoricoxib 10 mg	Etoricoxib 30 mg	Etoricoxib 60 mg	Etoricoxib 90 mg	Total
Yes	139	134	126	119	136	654
No	22	20	25	21	19	107

Methotrexate User
Methotrexate User(Participants)	Placebo	Etoricoxib 10 mg	Etoricoxib 30 mg	Etoricoxib 60 mg	Etoricoxib 90 mg	Total
Yes	99	91	96	93	93	472
No	62	63	55	47	62	289

Race/Ethnicity
Race/Ethnicity(participants)	Placebo	Etoricoxib 10 mg	Etoricoxib 30 mg	Etoricoxib 60 mg	Etoricoxib 90 mg	Total
Asian	1	0	1	1	1	4
Black	5	8	3	7	6	29
White	114	106	121	96	112	549
Hispanic	41	39	25	34	36	175
Native American	0	0	1	2	0	3
Indian	0	1	0	0	0	1

10 further baseline measures are reported on the registry.

Study locations

No study locations are listed for this record.

References and documents

Publications

Greenwald M, Peloso PM, Mandel D, Soto O, Mehta A, Frontera N, Boice JA, Zhan XJ, Curtis SP. Further assessment of the clinically effective dose range of etoricoxib: a randomized, double-blinded, placebo-controlled trial in rheumatoid arthritis. Curr Med Res Opin. 2011 Oct;27(10):2033-42. doi: 10.1185/03007995.2011.614935. Epub 2011 Sep 12. PubMed 21905970 ↗
Kvien TK, Greenwald M, Peloso PM, Wang H, Mehta A, Gammaitoni A. Do COX-2 inhibitors provide additional pain relief and anti-inflammatory effects in patients with rheumatoid arthritis who are on biological disease-modifying anti-rheumatic drugs and/or corticosteroids? Post-hoc analyses from a randomized clinical trial with etoricoxib. BMC Musculoskelet Disord. 2015 Feb 13;16:26. doi: 10.1186/s12891-015-0468-7. PubMed 25886874 ↗

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2006, a primary completion of Mar 2008 and a completion of Mar 2008. It does not say whether these dates are actual or estimated.

Results were first posted in Jul 2009, 1 year 4 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Dec 9, 2005
First posted: Dec 12, 2005
Start: Jan 2006
Primary completionActual: Mar 2008
CompletionActual: Mar 2008
Results first posted: Jul 7, 2009
Last update: Feb 9, 2022

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Feb 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00264147
Lead sponsor: Organon and Co
Responsible party: Sponsor
First posted: Dec 12, 2005
Start date: Jan 2006
Primary completion: Mar 2008
Completion: Mar 2008
Results posted: Jul 7, 2009
Last update: Feb 9, 2022

Study contacts

Medical Monitor

study director · Merck Sharp & Dohme LLC

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Etoricoxib

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Rheumatoid Arthritis Dose Ranging Study (0663-086)(COMPLETED)

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