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Monoclonal Antibodies

Open Label for Psoriasis

Phase 3
Waitlist Available
Research Sponsored by Abbott
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4 and week 16
Awards & highlights

Summary

The objective of this study was to evaluate the safety and efficacy profile of Humira (adalimumab) in patients who had a sub-optimal response to prior systemic therapy. This open-label study was conducted in a patient population of moderate to severe chronic plaque psoriasis patients, which is an approved patient population for adalimumab.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4 and week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4 and week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Who Achieved a Physician's Global Assessment (PGA) of Clear (0) or Minimal (1) at Week 16
Secondary outcome measures
Dermatology Life Quality Index (DLQI) Total Score
Number of Participants Achieving 0 or 1 on Patient's Global Assessment at Weeks 2, 4, and 8
Number of Participants Achieving DLQI Total Score of 0 at Week 4 and Week 16
+7 more

Side effects data

From 2020 Phase 4 trial • 4372 Patients • NCT02092467
22%
Upper respiratory tract infection
15%
Bronchitis
13%
Rheumatoid arthritis
13%
Urinary tract infection
12%
Nasopharyngitis
12%
Fall
12%
Herpes zoster
9%
Hypertension
8%
Arthralgia
7%
Diarrhoea
7%
Lymphopenia
7%
Sinusitis
7%
Back pain
6%
Osteoarthritis
6%
Influenza
6%
Latent tuberculosis
6%
Pharyngitis
5%
Nausea
5%
Anaemia
5%
Alanine aminotransferase increased
5%
Cough
4%
Gastroenteritis
3%
Pneumonia
3%
Headache
1%
Coronary artery disease
1%
Femur fracture
1%
Cellulitis
1%
Pulmonary embolism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tofacitinib 5 mg BID
Tofacitinib 10 mg BID
TNFi

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open LabelExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Adalimumab
FDA approved

Find a Location

Who is running the clinical trial?

AbbottLead Sponsor
752 Previous Clinical Trials
478,010 Total Patients Enrolled
22 Trials studying Psoriasis
5,259 Patients Enrolled for Psoriasis
Martin M Okun, M.D., Ph.D.Study DirectorAbbott
~9 spots leftby Sep 2025
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