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)

• Status: Recruiting
• Trial end date: 0000-00-00
• Target enrollment: 200
• Participant gender: Both

Summary

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Adalimumab
• Last Updated: 2016-12-15

Criteria

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.