|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Condition: |
Psoriasis |
| Intervention: |
Biological: adalimumab |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Japanese participants with chronic plaque psoriasis who completed the blinded, placebo-controlled Study M04-688 (NCT00338754; 24-week duration) enrolled in the extension study, M04-702, an open-label study until adalimumab received approval for treatment of psoriasis in Japan. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
| Description | |
|---|---|
| Adalimumab 40 mg Every Other Week | Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study. |
| Adalimumab 80 mg Every Other Week | Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure). |
| Adalimumab 40 mg Every Other Week | Adalimumab 80 mg Every Other Week | |
|---|---|---|
| STARTED | 89 | 58 |
| COMPLETED | 67 | 45 |
| NOT COMPLETED | 22 | 13 |
Baseline Characteristics
| Description | |
|---|---|
| Adalimumab 40 mg Every Other Week | Participants who had received adalimumab 40 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 40 mg eow during this study. |
| Adalimumab 80 mg Every Other Week | Participants who had received adalimumab 80 mg eow during Study M04-688 (NCT00338754) or who had received placebo during Study M04-688 (NCT00338754) and were re-randomized to receive adalimumab 80 mg eow during this study. All participants had to reduce their dosage to adalimumab 40 mg eow at Week 28 (after 52 or 28 weeks of total adalimumab exposure). |
| Adalimumab 40 mg Every Other Week | Adalimumab 80 mg Every Other Week | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
89 | 58 | 147 |
|
Age
[units: participants] |
|||
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 80 | 56 | 136 |
| >=65 years | 9 | 2 | 11 |
|
Age
[units: years] Mean ± Standard Deviation |
45.1 ± 13.39 | 42.9 ± 11.88 | 44.2 ± 12.82 |
|
Gender
[units: participants] |
|||
| Female | 13 | 10 | 23 |
| Male | 76 | 48 | 124 |
|
Region of Enrollment
[units: participants] |
|||
| Japan | 89 | 58 | 147 |
Outcome Measures
| 1. Primary: | Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response) [ Time Frame: Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab ] |
| 2. Secondary: | Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response) [ Time Frame: Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab ] |
| 3. Secondary: | Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response) [ Time Frame: Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab ] |
More Information
| Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
| There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
|
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
| Responsible Party: | Eiichi Makino, Abbott |
| ClinicalTrials.gov Identifier: | NCT00647400 History of Changes |
| Other Study ID Numbers: | M04-702 |
| Study First Received: | March 27, 2008 |
| Results First Received: | December 4, 2009 |
| Last Updated: | April 1, 2011 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |