A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected Via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) Subjects



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 99
Updated:8/22/2018
Start Date:December 15, 2014
End Date:August 8, 2018

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A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected Via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) Subjects (PREDICTRA)

A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected via Imaging
TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of
Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) Subjects (PREDICTRA).


Inclusion Criteria:

1. Subject has a diagnosis of rheumatoid arthritis (RA) as defined by the 1987 revised
American College of Rheumatology (ACR) classification criteria and/or the ACR
/European League Against Rheumatism (EULAR) 2010 classification criteria (any duration
since diagnosis).

2. Subject must meet the following criteria:

- Must be treated with adalimumab 40 mg sc eow for at least 12 months prior to Week
0 Visit

- Must be treated with concomitant MTX at a stable dose (oral, sc or im at any
dose) for at least 12 weeks prior to Week 0 Visit or if not on MTX, must be
treated with other allowed csDMARDs at stable dose for at least 12 weeks prior to
Week 0 Visit or if not treated with csDMARDs must maintain this regimen for at
least 12 weeks prior to Week 0 Visit.

3. Subject must be in sustained clinical remission based on the following:

- At least one documented 4 or 3 (if PGA is not available) variables DAS28 (ESR) or
DAS28 (CRP) < 2.6 (or calculated based on documented components of the DAS28) in
the patient chart 6 months or longer prior to the Screening Visit;

- 4 variables DAS28 (ESR) assessed at Screening < 2.6, with all components
including ESR assessed at Screening.

4. If subjects are receiving concomitant allowed csDMARDs (in addition or not to MTX) the
dose must be stable for at least 12 weeks prior to the Week 0 Visit (e.g.,
chloroquine, hydroxychloroquine, sulfasalazine, gold formulations [including
auranofin, gold sodium thiomalate, and aurothioglucose] and/or leflunomide).

5. If subjects are receiving concomitant oral corticosteroids, prednisone or equivalent
must be < 10 mg/day and the dose must be stable for at least 4 weeks prior to the
Screening Visit.

6. If subjects are receiving concomitant non-steroidal anti-inflammatory drugs (NSAIDs),
tramadol or other equivalent opioids and/or non-opioid analgesics, the dose and/or
therapeutic scheme must be stable for at least 4 weeks prior to the Week 0 Visit.

7. Subject must be able and willing to provide written informed consent and comply with
the requirements of this study protocol.

Exclusion Criteria:

1. Any 4 or 3 (if PGA is not available) variables DAS28 (ESR) or DAS28 (CRP) (or
calculated based on documented components of the DAS28) assessed within 6 months prior
to the Screening Visit ≥ 2.6.

2. Subject is on an additional concomitant biological disease-modifying anti-rheumatic
drug (bDMARD) (including but not limited to abatacept, anakinra, certolizumab,
etanercept, golimumab, infliximab, rituximab or tocilizumab).

3. Subject has been treated with intra-articular or parenteral corticosteroids within the
last four weeks before Screening.

4. Subject has undergone joint surgery within 12 weeks of Screening (at joints to be
assessed by magnetic resonance imaging (MRI) and/or ultrasound).

5. Subject has a medical condition precluding an MRI (e.g. magnetic activated implanted
devices - cardiac pace-maker, insulin pump, neuro stimulators, etc. and metallic
devices or fragments or clips in the eye, brain or spinal canal and in the hand/wrist
undergoing MRI)

6. Subject has a medical condition precluding a contrast MRI with gadolinium [e.g.
nephrogenic systemic fibrosis, previous anaphylactic/anaphylactoid reaction to
gadolinium containing contrast agent, pregnancy or breast feeding, severe renal
insufficiency with an estimated Glomerular Filtration Rate (eGFR) below 0
mL/min/1.73m2 at Screening, hepato-renal syndrome, severe chronic liver function
impairment]

7. Subject has been treated with any investigational drug of chemical or biologic nature
within a minimum of 30 days or five half-lives (whichever is longer) of the drug prior
to the Screening Visit.
We found this trial at
14
sites
Tuscaloosa, Alabama 35406
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Tuscaloosa, AL
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Bronx, NY
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Camperdown, New South Wales
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Camperdown,
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712 North Washington Avenue
Dallas, Texas 75246
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from
Dallas, TX
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Duncansville, Pennsylvania 16635
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from
Duncansville, PA
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Grand Blanc, Michigan 48439
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from
Grand Blanc, MI
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Jackson, Tennessee 38305
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from
Jackson, TN
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Jacksonville, Florida 32209
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from
Jacksonville, FL
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Lawrenceville, Georgia 30045
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from
Lawrenceville, GA
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3402 Magnolia Cove
Monroe, Louisiana 71203
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from
Monroe, LA
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Raleigh, North Carolina 27617
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from
Raleigh, NC
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Summerville, South Carolina 29486
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from
Summerville, SC
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from
Thousand Oaks, CA
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Tupelo, Mississippi 38801
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from
Tupelo, MS
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