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

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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)

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)

Trial documents
2

Trial contacts and locations

60

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Data sourced from clinicaltrials.gov

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