Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
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| ClinicalTrials.gov Identifier: NCT00195676 |
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Recruitment Status :
Completed
First Posted : September 20, 2005
Results First Posted : November 19, 2010
Last Update Posted : April 13, 2011
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Sponsor:
Abbott
Information provided by:
Abbott
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Brief Summary:
The two objectives of this study were to evaluate long-term efficacy and safety of adalimumab treatment in participants who had moderate to severe chronic plaque psoriasis and to evaluate the effectiveness of adalimumab retreatment in participants who had therapeutic response to adalimumab and were then withdrawn from adalimumab treatment.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Psoriasis | Drug: adalimumab | Phase 3 |
Study M03-658 was a continuation study for participants with moderate to severe psoriasis who had participated in a prior psoriasis adalimumab study. Study M03-658 consisted of three sequential treatment periods. The first period was Period O, in which participants received open-label treatment with adalimumab (40 mg every other week or 40 mg every week) for a minimum of 104 weeks and a maximum of 252 weeks. Period O was the only period of the study until May 2008, when the subsequent periods were added via amendment to the protocol. At that time, participants who had achieved satisfactory therapeutic response (a Physician's Global Assessment [PGA] of 0, 1, or 2 [clear, minimal, or mild]) were given the opportunity to discontinue from the study or to continue and participate in the subsequent two periods. The second period was Period W, a maximum of 52 weeks, in which participants with a PGA of 2 (mild) or less were withdrawn from adalimumab treatment (i.e., participants received no treatment) until relapse of their psoriasis occurred (defined as a PGA of 3 [moderate] or worse). The third period was Period R, a 16-week period in which participants were retreated with open-label adalimumab (80 mg initial dose followed by 40 mg every other week). Period O was designed to evaluate the first objective regarding long-term efficacy and safety of adalimumab treatment, and Period R was designed to evaluate the effectiveness of adalimumab retreatment following relapse. Specific subsets of the study population that were identified as the populations of interest were the modified intent-to-treat populations for Period W and Period R, and these are described further in the outcome measures.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1469 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter Open-Label Continuation Study in Moderate to Severe Chronic Plaque Psoriasis Subjects Who Completed a Preceding Psoriasis Clinical Study With Adalimumab |
| Study Start Date : | May 2004 |
| Actual Primary Completion Date : | October 2009 |
| Actual Study Completion Date : | October 2009 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Psoriasis
Drug Information available for:
Adalimumab
| Arm | Intervention/treatment |
|---|---|
| Adalimumab |
Drug: adalimumab
40 mg every other week or 40 mg every week by subcutaneous injection
Other Names:
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Primary Outcome Measures :
- Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R [ Time Frame: Week 16 of Period R ]The Physician's Global Assessment [PGA] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1.
Other Outcome Measures:
- Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 60 [ Time Frame: Week 60 ]The Physician's Global Assessment [PGA] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1.
- Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at Week 120 [ Time Frame: Week 120 ]The Physician's Global Assessment [PGA] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1.
- Percentage of Participants Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 60 [ Time Frame: Week 60 ]Psoriasis Area and Severity Index (PASI) scores were calculated from assessments at 4 designated anatomical sites (head, upper extremities, trunk, lower extremities) using both severity and area subscores (i.e., degree of and amount of psoriatic involvement per site). PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. Positive percent decreases indicate improvement, with the best improvement being 100%. A PASI 75 response was at least a 75% reduction in PASI score from baseline PASI score of the initial study.
- Percentage of Participants Who Achieved a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 120 [ Time Frame: Week 120 ]Psoriasis Area and Severity Index (PASI) scores were calculated from assessments at 4 designated anatomical sites (head, upper extremities, trunk, lower extremities) using both severity and area subscores (i.e., degree of and amount of psoriatic involvement per site). PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. Positive percent decreases indicate improvement, with the best improvement being 100%. A PASI 75 response was at least a 75% reduction in PASI score from baseline PASI score of the initial study.
- Time to Relapse in Period W [ Time Frame: Period W ]Relapse of psoriasis was defined as a Physician's Global Assessment (assessment of overall lesion severity) score of greater than or equal to 3 (3=moderate; 4=severe; 5=very severe).
- Percentage of Period R Modified Intent-to-Treat Participants Who Relapsed in Period W and Subsequently Had a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R [ Time Frame: Week 16 of Period R ]The Physician's Global Assessment [PGA] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1.
- Percentage of Period R Modified Intent-to-Treat Participants Who Did Not Relapse in Period W and Subsequently Had a Physician's Global Assessment of Clear or Minimal at Week 16 of Period R [ Time Frame: Week 16 of Period R ]The Physician's Global Assessment [PGA] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history.
- Subjects who met the requirements from previous adalimumab psoriasis study participation.
Exclusion Criteria:
- Subject considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
- Female subject who was pregnant or breast-feeding or considering becoming pregnant.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00195676
Locations
Show 104 study locations
Sponsors and Collaborators
Abbott
Investigators
| Study Director: | Martin Okun, MD, PhD | Abbott |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Martin M. Okun, MD, PhD/Medical Director, Immunology, Abbott |
| ClinicalTrials.gov Identifier: | NCT00195676 |
| Other Study ID Numbers: |
M03-658 2005-000095-41 ( EudraCT Number ) |
| First Posted: | September 20, 2005 Key Record Dates |
| Results First Posted: | November 19, 2010 |
| Last Update Posted: | April 13, 2011 |
| Last Verified: | April 2011 |
Additional relevant MeSH terms:
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Psoriasis Skin Diseases, Papulosquamous Skin Diseases |
Adalimumab Anti-Inflammatory Agents Antirheumatic Agents |