A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

AbbVie

Status and phase: Completed; Phase 4

Conditions: Psoriatic Arthritis

Treatments: Biological: adalimumab (ADA); Drug: methotrexate (MTX)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02814175

M14-496

2016-000191-21 (EudraCT Number)

Details and patient eligibility

About

An interventional Phase 4 open-label, randomized, controlled, parallel-group, multi-country study in participants with psoriatic arthritis (PsA) consisting of 2 parts: Part 1 (Day 1 up to Week 16) is designed to compare the achievement of minimal disease activity (MDA) between participants randomized to either adalimumab in combination with methotrexate (MTX) or MTX alone escalated to the highest recommended or tolerable dose; Part 2 (Week 16 through Week 32) is designed to evaluate the maintenance or achievement of MDA on 4 different treatment regimens using adalimumab and/or MTX, with participant allocation based on the initial randomized treatment and achievement of MDA in Part 1, and with rescue treatment option.

Enrollment: 246 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. PsA diagnosis established at least 4 weeks prior to the date of the Screening visit and confirmed by ClASsification of Psoriatic Arthritis (CASPAR) criteria
2. Not in MDA at the time of screening
3. Has 3 or more tender and 3 or more swollen joints
4. Treated with methotrexate 15 mg (weekly) for at least 4 weeks

Exclusion criteria

1. Contraindications to adalimumab therapy and/or known hypersensitivity to adalimumab or its excipients
2. History of methotrexate intolerance/toxicity
3. Medical conditions(s) precluding methotrexate dose increase above 15 mg
4. Had prior exposure to any tumor necrosis factor (TNF) inhibitor, other mechanism of action biologic DMARD (bDMARD) or any systemic biologic agent in general

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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246 participants in 6 patient groups

Part 1: MTX Escalated Dose

Active Comparator group

Description:

Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew)

Treatment:

Drug: methotrexate (MTX)

Part 1: ADA + MTX

Experimental group

Description:

Adalimumab (ADA) 40 mg every other week (eow) in combination with MTX 15 mg ew

Treatment:

Drug: methotrexate (MTX)

Biological: adalimumab (ADA)

Part 2: MTX Escalated Dose

Active Comparator group

Description:

Participants achieving minimal disease activity (MDA) at Week 16 on MTX escalated to 20 -25 mg or highest tolerable dose ew, continued with the same MTX dose

Treatment:

Drug: methotrexate (MTX)

Part 2: ADA + MTX Escalated Dose

Active Comparator group

Description:

Participants not achieving MDA at Week 16 on MTX escalated to 20 - 25 mg or highest tolerable dose ew, received ADA 40 mg eow in combination with MTX 20 - 25 mg or highest tolerable dose ew

Treatment:

Drug: methotrexate (MTX)

Biological: adalimumab (ADA)

Part 2: ADA

Experimental group

Description:

Participants achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had MTX completely withdrawn at Week 16 and continued receiving ADA as monotherapy

Treatment:

Biological: adalimumab (ADA)

Part 2: ADA ew + MTX

Experimental group

Description:

Participants not achieving MDA at Week 16 on ADA 40 mg eow plus MTX 15 mg ew, had ADA escalated to 40 mg ew in combination with MTX 15 mg ew

Treatment:

Drug: methotrexate (MTX)

Biological: adalimumab (ADA)