Trial Outcomes & Findings for Assessment of the Response to Etoricoxib in Patients With Ankylosing Spondylitis and Inadequate Response to ≥2 NSAIDs (NCT NCT01091675)

Last Updated: 2015-08-25

Results Overview

BASDAI Bath Ankylosing Spondylitis Disease Activity Index, is the gold standard for measuring and evaluating disease activity in Ankylosing Spondylitis consists of a one through 10 scale which is used to answer 6 questions pertaining to the 5 major symptoms of AS. BASDAI has been used to assess the efficacy of the treatment. Possible Patients were considerate respond to ASABIO criteria when presented a change of 2 in the BASDAI score range.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

58 participants

Primary outcome timeframe

the ASAS response were evaluated at week 2 and 4 and after 6 months treatment

Results posted on

2015-08-25

Participant Flow

The study enrolled 58 patients in total, with ankylosing spondylitis, and Inadequate response to ≥2 NSAIDs. Patients who met The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores of 4 or higher and all study criteria participate in the study and were randomized at 14 study sites. The last patient completed in May 2013.

From a total of 58 patients recruited 1 did not met the exclusion criteria, so 57 patients start the first phase. 4 patients abandoned the study due to hypertension. 53 patients completed the first phase. 27 did not proceed to phase 2 due to lack of efficacy and 3 patients were withdraw due to hypertension. 23 patients complete the study period.

Participant milestones

Participant milestones
Measure	Etoricoxib All the patients who fulfil the eligibility criteria will start a 4-week open label treatment period to evaluate the response to treatment with etoricoxib 90 mg. Etoricoxib: Etoricoxib 90 mg/day/PO during 4 weeks Positive response to the therapy (in investigator opinion): Ongoing treatment with 90 mg/day/PO until 24 weeks.
Overall Study STARTED	57
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	34

Reasons for withdrawal

Reasons for withdrawal
Measure	Etoricoxib All the patients who fulfil the eligibility criteria will start a 4-week open label treatment period to evaluate the response to treatment with etoricoxib 90 mg. Etoricoxib: Etoricoxib 90 mg/day/PO during 4 weeks Positive response to the therapy (in investigator opinion): Ongoing treatment with 90 mg/day/PO until 24 weeks.
Overall Study Adverse Event	7
Overall Study Lack of Efficacy	27

Baseline Characteristics

Assessment of the Response to Etoricoxib in Patients With Ankylosing Spondylitis and Inadequate Response to ≥2 NSAIDs

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Etoricoxib n=58 Participants All the patients who fulfil the eligibility criteria will start a 4-week open label treatment period to evaluate the response to treatment with etoricoxib 90 mg. Etoricoxib: Etoricoxib 90 mg/day/PO during 4 weeks Positive response to the therapy (in investigator opinion): Ongoing treatment with 90 mg/day/PO until 24 weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	58 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	44 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	55 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	55 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Spain	58 participants n=5 Participants

PRIMARY outcome

Timeframe: the ASAS response were evaluated at week 2 and 4 and after 6 months treatment

Population: Patients with physician-diagnosed Ankylosing Spondylitis at 6 months before study start

Outcome measures

Outcome measures
Measure	Etoricoxib n=57 Participants All the patients who fulfil the eligibility criteria will start a 4-week open label treatment period to evaluate the response to treatment with etoricoxib 90 mg. Etoricoxib: Etoricoxib 90 mg/day/PO during 4 weeks Positive response to the therapy (in investigator opinion): Ongoing treatment with 90 mg/day/PO until 24 weeks.
the Percentage of Patients Fulfilling the Assessment Study (ASAS) Response Criteria Were Determined	19 percentage of participants Interval 10.0 to 30.0

Adverse Events

Etoricoxib

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Etoricoxib n=57 participants at risk All the patients who fulfil the eligibility criteria will start a 4-week open label treatment period to evaluate the response to treatment with etoricoxib 90 mg. Etoricoxib: Etoricoxib 90 mg/day/PO during 4 weeks Positive response to the therapy (in investigator opinion): Ongoing treatment with 90 mg/day/PO until 24 weeks.
Vascular disorders cavernous hemangioma	1.8% 1/57 • Number of events 1 • from September 23rd 2010 until May 28th 2013

Other adverse events

Other adverse events
Measure	Etoricoxib n=57 participants at risk All the patients who fulfil the eligibility criteria will start a 4-week open label treatment period to evaluate the response to treatment with etoricoxib 90 mg. Etoricoxib: Etoricoxib 90 mg/day/PO during 4 weeks Positive response to the therapy (in investigator opinion): Ongoing treatment with 90 mg/day/PO until 24 weeks.
Cardiac disorders Tachycardia	5.3% 3/57 • from September 23rd 2010 until May 28th 2013
Nervous system disorders headache	3.5% 2/57 • from September 23rd 2010 until May 28th 2013
General disorders anxiety	3.5% 2/57 • from September 23rd 2010 until May 28th 2013
General disorders Nervousness	3.5% 2/57 • from September 23rd 2010 until May 28th 2013
General disorders cold	3.5% 2/57 • from September 23rd 2010 until May 28th 2013
Infections and infestations upper respiratory infection	1.8% 1/57 • from September 23rd 2010 until May 28th 2013
Metabolism and nutrition disorders weight gain	1.8% 1/57 • from September 23rd 2010 until May 28th 2013
General disorders arterial hypertension	12.3% 7/57 • from September 23rd 2010 until May 28th 2013

Additional Information

Dr. Jordi Gratacós Masmitjá

Unidad de Reumatología, Hospital Parc Tauli de Sabadell. Institut Universitari UAB

Phone: 937.23.10.10

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER