Open Label Study of Adalimumab in Subjects Who Have a Sub-optimal Response to Systemic Therapy or Phototherapy

Psoriasis Clinical Trial

Official title:

Open Label Study of Adalimumab in Subjects Who Have a Sub-optimal Response to Systemic Therapy or Phototherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00566722
• Other study ID #: M10-238
• Status: Completed
• Phase: Phase 3
• First received: December 1, 2007
• Last updated: April 8, 2011
• Start date: January 2008
• Est. completion date: April 2009

Study information

• Verified date: April 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

This 16-week multicenter, open-label study was designed to evaluate the efficacy and safety of a loading dose of 80 mg adalimumab, followed by 40 mg adalimumab every other week in the treatment of psoriasis in patients with a sub-optimal response to etanercept, methotrexate (MTX), or Narrow band Ultraviolet − B (NB-UVB).

Approximately 150 participants were planned for 3 sub-studies: 80 participants with sub-optimal response to etanercept, 40 participants with sub-optimal response to MTX, and 30 participants with sub-optimal response to NB-UVB. Actual enrollment was 82 participants with sub-optimal response to etanercept, 41 participants with sub-optimal response to MTX, and 29 participants with sub-optimal response to NB-UVB.

Screening was performed at least 96 hours and no more than 31 days before the Baseline visit (Week 0). A participant who was eligible for the study based on sub-optimal response to one treatment (MTX, NB-UVB, or etanercept) was required to discontinue that treatment within a specified time before first dose of adalimumab (see descriptions of sub-study groups). In addition, if the participant was also receiving another qualifying treatment, he/she was required to have discontinued the other treatment at least 30 days before the Baseline visit (Week 0).

Adalimumab was administered by subcutaneous (SC) injection. At the Baseline Visit (Week 0), all participants received an initial dose of 80 mg adalimumab SC. Every other week (odd-numbered weeks) from Week 1 to Week 15, participants received 40 mg adalimumab SC.

This was a single group assignment study, that is, all participants received the same treatment; however, data were summarized for 3 groups (sub-studies) that were defined by psoriasis treatments participants received before entering this study: methotrexate, etanercept, or narrow-band, ultraviolet-B.

Efficacy was evaluated using the Physician's Global Assessment (PGA) of disease severity, and patient-reported outcomes: Patient's Global Assessment (PTGA) of disease severity, the Psoriasis-related Pruritus Assessment, the Dermatology Life Quality Index (DLQI), a visual analog scale (VAS) for plaque psoriasis and psoriatic arthritis pain, the Medical Outcomes Study (MOS) Sleep Scale, and the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI: SHP).

Serious and nonserious adverse events were summarized by sub-study of participants (suboptimal response to MTX, suboptimal response to NB-UVB, and suboptimal response to etanercept).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of chronic plaque psoriasis with disease duration of at least 6 months

• Sub-optimal response to treatment with etanercept, methotrexate, or narrow-band UVB phototherapy

Exclusion Criteria:

• Prior treatment with adalimumab

• Multiple concomitant therapy restrictions and/or washouts (topicals, ultraviolet, other systemic psoriasis therapies)

• Prior treatment with natalizumab

• Concurrent active skin diseases/infections

• Poorly controlled medical conditions

• History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease

• History of certain cancers

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Biological:
• adalimumab
Participants received an 80 mg adalimumab loading dose by subcutaneous injection at Baseline (Week 0). From Week 1 to Week 15, participants received 40 mg adalimumab by subcutaneous injection every other week.

Locations

Country	Name	City	State
Canada	Kirk Barber Research	Calgary	Alberta
Canada	Stratica Medical	Edmonton	Alberta
Canada	Eastern Canada Cutaneous Research Associates	Halifax	Nova Scotia
Canada	Dermatrials Research	Hamilton	Ontario
Canada	Siena Medical Research	Montreal	Quebec
Canada	Centre de Rescherche Dermatologique Du Quebec Metropolitain	Quebec City	Quebec
Canada	K.Papp Clinical Research Inc	Waterloo	Ontario
United States	ORA Clinical Research and Development	Andover	Massachusetts
United States	Peachtree Dermatology Associates	Atlanta	Georgia
United States	Total Skin and Beauty Dermatology Centers	Birmingham	Alabama
United States	Montifiore Medical Center	Bronx	New York
United States	Baylor Research Institute	Dallas	Texas
United States	Dermatology Treatment & Research Center, PA Research	Dallas	Texas
United States	Radiant Research	Greer	South Carolina
United States	Center for Clinical Studies	Houston	Texas
United States	Dawes Fretzin Clinical Research Group	Indianapolis	Indiana
United States	Clinical Partners	Johnston	Rhode Island
United States	Dermatology Research of Arkansas	Little Rock	Arkansas
United States	Florida Academic Dermatology Centers	Miami	Florida
United States	Mount Sinai School of Medicine	New York	New York
United States	New York University School of Medicine	New York	New York
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	Paddington Testing Co.	Philadelphia	Pennsylvania
United States	Therapeutics Clinical Research	San Diego	California
United States	Dermatology Associates	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Achieved a Physician's Global Assessment (PGA) of Clear (0) or Minimal (1) at Week 16	The PGA is a 6-point scale used to measure the severity of a patient's disease. Plaque elevation, scaling, and erythema are rated from 0= clear (no plaque elevation; no scaling; erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration) to 5=very severe (plaque elevation=very marked; scaling=very coarse; erythema=very severe [extreme red coloration, dusky to deep red coloration]).	Week 16	No
Secondary	Number of Participants Achieving a PGA of Clear (0) at Week 16		Week 16	No
Secondary	Number of Participants Achieving at Least 1 Grade of Improvement in PGA at Week 16 Compared to Screening		From Screening to Week 16	No
Secondary	Number of Participants Achieving 0 or 1 on Patient's Global Assessment at Weeks 2, 4, and 8	The Patient's Global Assessment of Psoriasis-Severity is a rating of how well their disease is controlled. 0=complete disease control; 1=good disease control; 2=limited disease control; 3=uncontrolled disease.	Weeks 2, 4, and 8	No
Secondary	Dermatology Life Quality Index (DLQI) Total Score	The DLQI has 10 items and 6 subscales: symptoms and feelings (Q 1 and 2), daily activities (Q 3 and 4), leisure (Q 5 and 6), work and school (Q 7), personal relationships (Q 8 and 9), and treatment (Q 10). Participants rate how much their skin problem affected their life in previous week. Responses are 0 (not at all) to 3=very much. DLQI=total of scores for all items; max=30; min=0.	From Screening to Week 4 and Week 16	No
Secondary	Number of Participants Achieving DLQI Total Score of 0 at Week 4 and Week 16	DLQI total score of 0 indicates psoriasis had no effect at all on participant's life.	Week 4 and Week 16	No
Secondary	Psoriasis-related Pruritus Assessment	The Psoriasis-related Pruritus Assessment is a scale for evaluating pruritus-related to psoriasis over the previous week; values range from 0 (no itching) to 10 (severe itching). A decrease in score indicates an improvement in pruritus.	From Screening to Week 16	No
Secondary	Visual Analog Scale (VAS) for Pain Involving Psoriatic Plaques and/or Psoriatic Arthritis	The participant rates his/her pain during the previous week on a 100 mm VAS, from 0=no pain to 100=pain as bad as it could be. A decrease in score indicates improvement.	From Screening to Week 16	No
Secondary	Percent Work Time Missed Due to Psoriasis	Work and activity impairment due to psoriasis were evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP), a 6-item questionnaire that measures effect of psoriasis on number of hours worked and the number of hours missed from work. It also measures the effect on productivity and regular activities: 0=no effect on work/daily activities; 10=psoriasis prevented me from working/doing daily activities. Decreases in values on each part indicate improvement. At Screening, percent time missed in the previous week ranged from 0% to 40%.	From Screening to Week 16	No
Secondary	Percent Overall Work Impairment Due to Psoriasis	Percent overall work impairment was evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) (described above). At Screening, overall impairment ranged from 0% to 94%. A decrease in percent overall work impairment indicates improvement.	From Screening to Week 16	No
Secondary	Percent Impairment While Working Due to Psoriasis	Percent impairment while working was evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP), described above. At Screening, impairment while working ranged from 0% to 90%. A decrease in percent impairment indicates improvement.	From Screening to Week 16	No
Secondary	Percent Activity Impairment Due to Psoriasis	Percent impairment in regular activities was evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP), described above. At Screening, activity impairment due to psoriasis ranged from 0% to 90%.	From Screening to Week 16	No
Secondary	Sleep Problems Index II	Sleep Problems Index of the Sleep Scale from the Medical Outcomes Study reflects sleep disturbance, perceived sleep adequacy, daytime somnolence, and awakening short of breath or with headache. Participant rates each item from "none of the time" to "all of the time" for the previous 4 weeks. Scores are transformed to 0 to 100 scale; lower scores indicate less impairment. Decrease in score indicates improvement.	From Screening to Week 16	No