Individualizing Anti-Inflammatory Medications for Adults With Axial Spondyloarthritis: A Series of N-of 1 Trials

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-25

Study Completion Date

2023-08-11

Brief Summary

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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

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Detailed Description

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Conditions

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Axial Spondyloarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Celecoxib, Then Meloxicam, Then Naproxen, Then A, Then B

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. After these 3 initial treatment sessions, participants are then randomized to the 2 best-performing drugs for 2 additional treatment sessions \[randomized to either alphabetical order (A then B) or reverse alphabetical order (B then A)\] There will be no washout periods. All 3 medications will be over-encapsulated in identical opaque capsules.

Group Type EXPERIMENTAL

Celecoxib

Intervention Type DRUG

Celecoxib 200 mg capsules twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Naproxen

Intervention Type DRUG

Naproxen 500 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Meloxicam

Intervention Type DRUG

Meloxicam 7.5 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Celecoxib, Then Meloxicam, Then Naproxen, Then B, Then A

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. After these 3 initial treatment sessions, participants are then randomized to the 2 best-performing drugs for 2 additional treatment sessions \[randomized to either alphabetical order (A then B) or reverse alphabetical order (B then A)\] There will be no washout periods. All 3 medications will be over-encapsulated in identical opaque capsules.

Group Type EXPERIMENTAL

Celecoxib

Intervention Type DRUG

Celecoxib 200 mg capsules twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Naproxen

Intervention Type DRUG

Naproxen 500 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Meloxicam

Intervention Type DRUG

Meloxicam 7.5 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Celecoxib, Then Naproxen, Then Meloxicam, Then A, Then B

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. After these 3 initial treatment sessions, participants are then randomized to the 2 best-performing drugs for 2 additional treatment sessions \[randomized to either alphabetical order (A then B) or reverse alphabetical order (B then A)\] There will be no washout periods. All 3 medications will be over-encapsulated in identical opaque capsules.

Group Type EXPERIMENTAL

Celecoxib

Intervention Type DRUG

Celecoxib 200 mg capsules twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Naproxen

Intervention Type DRUG

Naproxen 500 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Meloxicam

Intervention Type DRUG

Meloxicam 7.5 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Celecoxib, Then Naproxen, Then Meloxicam, Then B, Then A

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. After these 3 initial treatment sessions, participants are then randomized to the 2 best-performing drugs for 2 additional treatment sessions \[randomized to either alphabetical order (A then B) or reverse alphabetical order (B then A)\] There will be no washout periods. All 3 medications will be over-encapsulated in identical opaque capsules.

Group Type EXPERIMENTAL

Celecoxib

Intervention Type DRUG

Celecoxib 200 mg capsules twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Naproxen

Intervention Type DRUG

Naproxen 500 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Meloxicam

Intervention Type DRUG

Meloxicam 7.5 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Meloxicam, Then Celecoxib, Then Naproxen, Then A, Then B

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. After these 3 initial treatment sessions, participants are then randomized to the 2 best-performing drugs for 2 additional treatment sessions \[randomized to either alphabetical order (A then B) or reverse alphabetical order (B then A)\] There will be no washout periods. All 3 medications will be over-encapsulated in identical opaque capsules.

Group Type EXPERIMENTAL

Celecoxib

Intervention Type DRUG

Celecoxib 200 mg capsules twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Naproxen

Intervention Type DRUG

Naproxen 500 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Meloxicam

Intervention Type DRUG

Meloxicam 7.5 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Meloxicam, Then Celecoxib, Then Naproxen, Then B, Then A

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. After these 3 initial treatment sessions, participants are then randomized to the 2 best-performing drugs for 2 additional treatment sessions \[randomized to either alphabetical order (A then B) or reverse alphabetical order (B then A)\] There will be no washout periods. All 3 medications will be over-encapsulated in identical opaque capsules.

Group Type EXPERIMENTAL

Celecoxib

Intervention Type DRUG

Celecoxib 200 mg capsules twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Naproxen

Intervention Type DRUG

Naproxen 500 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Meloxicam

Intervention Type DRUG

Meloxicam 7.5 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Meloxicam, Then Naproxen, Then Celecoxib, Then A, Then B

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. After these 3 initial treatment sessions, participants are then randomized to the 2 best-performing drugs for 2 additional treatment sessions \[randomized to either alphabetical order (A then B) or reverse alphabetical order (B then A)\] There will be no washout periods. All 3 medications will be over-encapsulated in identical opaque capsules.

Group Type EXPERIMENTAL

Celecoxib

Intervention Type DRUG

Celecoxib 200 mg capsules twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Naproxen

Intervention Type DRUG

Naproxen 500 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Meloxicam

Intervention Type DRUG

Meloxicam 7.5 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Meloxicam, Then Naproxen, Then Celecoxib, Then B, Then A

Each participant will be randomized to a different initial drug sequence (6 possibilities: ABC, 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. After these 3 initial treatment sessions, participants are then randomized to the 2 best-performing drugs for 2 additional treatment sessions \[randomized to either alphabetical order (A then B) or reverse alphabetical order (B then A)\] There will be no washout periods. All 3 medications will be over-encapsulated in identical opaque capsules.

Group Type EXPERIMENTAL

Celecoxib

Intervention Type DRUG

Celecoxib 200 mg capsules twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Naproxen

Intervention Type DRUG

Naproxen 500 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Meloxicam

Intervention Type DRUG

Meloxicam 7.5 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Naproxen, Then Celecoxib, Then Meloxicam, Then A, Then B

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. After these 3 initial treatment sessions, participants are then randomized to the 2 best-performing drugs for 2 additional treatment sessions \[randomized to either alphabetical order (A then B) or reverse alphabetical order (B then A)\] There will be no washout periods. All 3 medications will be over-encapsulated in identical opaque capsules.

Group Type EXPERIMENTAL

Celecoxib

Intervention Type DRUG

Celecoxib 200 mg capsules twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Naproxen

Intervention Type DRUG

Naproxen 500 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Meloxicam

Intervention Type DRUG

Meloxicam 7.5 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Naproxen, Then Celecoxib, Then Meloxicam, Then B, Then A

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. After these 3 initial treatment sessions, participants are then randomized to the 2 best-performing drugs for 2 additional treatment sessions \[randomized to either alphabetical order (A then B) or reverse alphabetical order (B then A)\] There will be no washout periods. All 3 medications will be over-encapsulated in identical opaque capsules.

Group Type EXPERIMENTAL

Celecoxib

Intervention Type DRUG

Celecoxib 200 mg capsules twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Naproxen

Intervention Type DRUG

Naproxen 500 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Meloxicam

Intervention Type DRUG

Meloxicam 7.5 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Naproxen, Then Meloxicam, Then Celecoxib, Then A, Then B

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. After these 3 initial treatment sessions, participants are then randomized to the 2 best-performing drugs for 2 additional treatment sessions \[randomized to either alphabetical order (A then B) or reverse alphabetical order (B then A)\] There will be no washout periods. All 3 medications will be over-encapsulated in identical opaque capsules.

Group Type EXPERIMENTAL

Celecoxib

Intervention Type DRUG

Celecoxib 200 mg capsules twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Naproxen

Intervention Type DRUG

Naproxen 500 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Meloxicam

Intervention Type DRUG

Meloxicam 7.5 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Naproxen, Then Meloxicam, Then Celecoxib, Then B, Then A

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. After these 3 initial treatment sessions, participants are then randomized to the 2 best-performing drugs for 2 additional treatment sessions \[randomized to either alphabetical order (A then B) or reverse alphabetical order (B then A)\] There will be no washout periods. All 3 medications will be over-encapsulated in identical opaque capsules.

Group Type EXPERIMENTAL

Celecoxib

Intervention Type DRUG

Celecoxib 200 mg capsules twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Naproxen

Intervention Type DRUG

Naproxen 500 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Meloxicam

Intervention Type DRUG

Meloxicam 7.5 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Interventions

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Celecoxib

Celecoxib 200 mg capsules twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Intervention Type DRUG

Naproxen

Naproxen 500 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Intervention Type DRUG

Meloxicam

Meloxicam 7.5 mg tablets twice daily (BID) All 3 medications will be over-encapsulated in identical opaque capsules

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No