Study of Two Dosing Schedules of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
This study has been completed.
Sponsor:
Abbott
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00645905
First received: March 26, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
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Purpose
Study of Two Dosing Schedules of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriasis |
Drug: adalimumab Drug: placebo for adalimumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Study of Two Dosing Schedules of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis |
Resource links provided by NLM:
Further study details as provided by Abbott:
Primary Outcome Measures:
- Psoriasis Area and Severity Index [ Time Frame: Week 12-Week 24 ] [ Designated as safety issue: No ]
- Adverse Events [ Time Frame: Throughout Study Participation ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Psoriasis Area and Severity Index [ Time Frame: Week 12, Week 24 through 360 days after last dose ] [ Designated as safety issue: No ]
- Physician's Global Assessment [ Time Frame: Week 12, Week 24 through 360 days after last dose ] [ Designated as safety issue: No ]
| Enrollment: | 148 |
| Study Start Date: | June 2003 |
| Primary Completion Date: | March 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: A |
Drug: adalimumab
OL 80 mg at Week 0, 40 mg weekly through Week 12, blinded 40 mg eow through Week 48, withdrawal and observation for 360 days after last dose
Other Names:
|
| Placebo Comparator: B |
Drug: placebo for adalimumab
OL 80 mg at Week 0, 40 mg weekly through Week 12, blinded placebo eow through Week 48, withdrawal and observation for 360 days after last dose
Other Name: placebo
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of moderate to severe chronic plaque psoriasis
- Active psoriasis, despite topical therapies
Exclusion Criteria:
- Other active skin diseases or skin infections
- Prior exposure to any anti-TNF therapy
- Subject has other active skin diseases
- Multiple concomitant therapy restrictions and/or washouts (topicals, UV, other systemic PS therapies)
- Poorly controlled medical conditions
- History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease
- History of cancer or lymphoproliferative disease
- History of active TB or listeriosis, or persistent chronic or active infections
- Known to have immune deficiency or is immunocompromised
- Clinically significant abnormal laboratory test results
- Erythrodermic psoriasis or generalized pustular psoriasis
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Beverly Paperiello / Director, Clinical Program Management, Abbott |
| ClinicalTrials.gov Identifier: | NCT00645905 History of Changes |
| Other Study ID Numbers: | M02-538 |
| Study First Received: | March 26, 2008 |
| Last Updated: | March 26, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Adalimumab |
Antirheumatic Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on June 18, 2013