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 an Active Drug in Clinical Remission Rheumatoid ArThritis (RA) Subjects

Brief summary

The primary objective of the study was to investigate the association between residual disease activity at Baseline as detected by Magnetic Resonance Imaging (MRI) and the occurrence of flares in participants with rheumatoid arthritis (RA) randomized to an active drug dose tapering regimen controlled by an active drug withdrawal.

Interventional study

Status:
Completed
Conditions:
Rheumatoid Arthritis
Musculoskeletal and Connective Tissue Diseases
Enrollment:
149 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M14-500
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Purpose:
Treatment

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Eligibility criteria

Participant attributes:
Male and Female

Age:

18 Years and older.

Inclusion Criteria:

1. Participant had 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. Participant must have met the following criteria:

- Must have been treated with adalimumab 40 mg subcutaneously every other week (sc
eow) for at least 12 months prior to Week 0 Visit

- Must have been treated with concomitant methotrexate (MTX) at a stable dose
(oral, sc or intramuscular (im) at any dose) for at least 12 weeks prior to Week
0 Visit or if not on MTX, must have been treated with other allowed conventional
synthetic disease-modifying anti-rheumatic drugs (csDMARDs) at a 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. Participant must be in sustained clinical remission based on the following:

- At least one documented 4 or 3 (if Patient's Global Assessment ; PGA is not
available) variables Disease Activity Score 28 Erythrocyte sedimentation rate
(DAS28 ESR) or DAS28 C-reactive protein (CRP) < 2.6 (or calculated based on
documented components of the DAS28) in the participant's 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 participant was receiving concomitant allowed csDMARDs (in addition or not to MTX)
the dose must have been 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 participant was receiving concomitant oral corticosteroids, prednisone or
equivalent must have been < 10 mg/day and the dose must have been stable for at least
4 weeks prior to the Week 0 Visit.

6. If participant was 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 have been stable for at least 4 weeks prior to the Week
0 Visit.

7. Participant must have been 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. Participant was 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. Participant had been treated with intra-articular or parenteral corticosteroids within
the last four weeks before Screening.

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

5. Participant had 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. Participant had 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 30
mL/min/1.73m^2 at Screening, hepato-renal syndrome, severe chronic liver function
impairment]

7. Participant had 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.

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