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

The University of Texas System (UT)

Status and phase: Terminated; Phase 2

Conditions: Axial Spondyloarthritis

Treatments: Drug: Meloxicam; Drug: Celecoxib; Drug: Naproxen

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04115098

HSC-MS-19-0677

KL2TR003168 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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42 participants in 12 patient groups

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

Experimental group

Description:

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.

Treatment:

Drug: Naproxen

Drug: Celecoxib

Drug: Meloxicam

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

Experimental group

Description:

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.

Treatment:

Drug: Naproxen

Drug: Celecoxib

Drug: Meloxicam

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

Experimental group

Description:

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.

Treatment:

Drug: Naproxen

Drug: Celecoxib

Drug: Meloxicam

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

Experimental group

Description:

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.

Treatment:

Drug: Naproxen

Drug: Celecoxib

Drug: Meloxicam

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

Experimental group

Description:

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.

Treatment:

Drug: Naproxen

Drug: Celecoxib

Drug: Meloxicam

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

Experimental group

Description:

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.

Treatment:

Drug: Naproxen

Drug: Celecoxib

Drug: Meloxicam

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

Experimental group

Description:

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.

Treatment:

Drug: Naproxen

Drug: Celecoxib

Drug: Meloxicam

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

Experimental group

Description:

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.

Treatment:

Drug: Naproxen

Drug: Celecoxib

Drug: Meloxicam

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

Experimental group

Description:

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.

Treatment:

Drug: Naproxen

Drug: Celecoxib

Drug: Meloxicam

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

Experimental group

Description:

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.

Treatment:

Drug: Naproxen

Drug: Celecoxib

Drug: Meloxicam

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

Experimental group

Description:

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.

Treatment:

Drug: Naproxen

Drug: Celecoxib

Drug: Meloxicam

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

Experimental group

Description:

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.

Treatment:

Drug: Naproxen

Drug: Celecoxib

Drug: Meloxicam