Purpose

The purpose of this study is to compare selective cyclooxygenase-2 (COX-2) and non selective COX inhibitors with respect to the extent to which disease activity is improved without self reported, unacceptable side effects among individual patients with axial spondyloarthritis (AxSpA),to compare selective COX-2 and nonselective COX inhibitors impact on Health related Quality of Life (HrQOL) and how this relates to changes in disease activity and to conduct proteomic assessment of predictive biomarkers of non steroidal anti-inflammatory drug(NSAID) response

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients must meet modified New York Classification and/or Assessment of Spondyloarthritis International Society (ASAS) criteria for Classification Criteria for AxSpA - Ankylosing Spondylitis Disease Activity Score greater than or equal to 2.1.

Exclusion Criteria

  • Changing background biologic/disease modifying-rheumatic medications within less than 3 months. - Opioid medication use - Current or expected pregnancy - History of cardiovascular disease (previous stroke, myocardial infarction, or percutaneous intervention. - End stage liver disease - Chronic Kidney Disease greater than Stage IIIb

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Drug order 1
  • Drug: Drug order 1
    each participant will be randomized to a different initial drug sequence (6 possibilities: ABC, ACB, BAC, BCA, CBA, CAB) of the following three drugs: Naproxen 500 mg tablets twice daily (BID), Meloxicam 7.5 mg tablets BID and Celecoxib 200 mg capsules BID. Patients will be randomized in blocks of 6 to ensure that no drug is assigned to be the first drug tested more often than the others. Medications will be obtained by the investigation team, and then all 3 medications will be overencapsulated in identical opaque capsules.
Experimental
Drug order 2
  • Drug: Drug order 2
    each participant will be randomized to a different initial drug sequence (6 possibilities: ABC, ACB, BAC, BCA, CBA, CAB) of the following three drugs: Naproxen 500 mg tablets twice daily (BID), Meloxicam 7.5 mg tablets BID and Celecoxib 200 mg capsules BID. Patients will be randomized in blocks of 6 to ensure that no drug is assigned to be the first drug tested more often than the others. Medications will be obtained by the investigation team, and then all 3 medications will be overencapsulated in identical opaque capsules.
Experimental
Drug order 3
  • Drug: Drug order 3
    each participant will be randomized to a different initial drug sequence (6 possibilities: ABC, ACB, BAC, BCA, CBA, CAB) of the following three drugs: Naproxen 500 mg tablets twice daily (BID), Meloxicam 7.5 mg tablets BID and Celecoxib 200 mg capsules BID. Patients will be randomized in blocks of 6 to ensure that no drug is assigned to be the first drug tested more often than the others. Medications will be obtained by the investigation team, and then all 3 medications will be overencapsulated in identical opaque capsules.
Experimental
Drug order 4
  • Drug: Drug order 4
    each participant will be randomized to a different initial drug sequence (6 possibilities: ABC, ACB, BAC, BCA, CBA, CAB) of the following three drugs: Naproxen 500 mg tablets twice daily (BID), Meloxicam 7.5 mg tablets BID and Celecoxib 200 mg capsules BID. Patients will be randomized in blocks of 6 to ensure that no drug is assigned to be the first drug tested more often than the others. Medications will be obtained by the investigation team, and then all 3 medications will be overencapsulated in identical opaque capsules.
Experimental
Drug order 5
  • Drug: Drug order 5
    each participant will be randomized to a different initial drug sequence (6 possibilities: ABC, ACB, BAC, BCA, CBA, CAB) of the following three drugs: Naproxen 500 mg tablets twice daily (BID), Meloxicam 7.5 mg tablets BID and Celecoxib 200 mg capsules BID. Patients will be randomized in blocks of 6 to ensure that no drug is assigned to be the first drug tested more often than the others. Medications will be obtained by the investigation team, and then all 3 medications will be overencapsulated in identical opaque capsules.
Experimental
Drug order 6
  • Drug: Drug order 6
    each participant will be randomized to a different initial drug sequence (6 possibilities: ABC, ACB, BAC, BCA, CBA, CAB) of the following three drugs: Naproxen 500 mg tablets twice daily (BID), Meloxicam 7.5 mg tablets BID and Celecoxib 200 mg capsules BID. Patients will be randomized in blocks of 6 to ensure that no drug is assigned to be the first drug tested more often than the others. Medications will be obtained by the investigation team, and then all 3 medications will be overencapsulated in identical opaque capsules.

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Mark C Hwang, MD
713-500-6900
Mark.C.Hwang@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Mark C Hwang, MD
713-500-6900
Mark.C.Hwang@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.