PsoriasisPhase 3NCT00195676
Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
A Phase 3 study testing adalimumab in people with Psoriasis, run by Abbott at 104 sites in 10 countries.
Trial 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the effectiveness of adalimumab retreatment in participants who had therapeutic response to adalimumab and were then withdrawn from… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,469 participants
- Where
- 104 sitesin 10 countries
- Study dates
- May 2004to Oct 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
104 sites in 10 countries.
104 sites in 10 countries
United States66 sites
Site Reference ID/Investigator# 98
Alpharetta, Georgia, 30022
Site Reference ID/Investigator# 1668
Andover, Massachusetts, 01810
Site Reference ID/Investigator# 93
Ann Arbor, Michigan, 48109
Site Reference ID/Investigator# 1798
Bakersfield, California, 93309
Site Reference ID/Investigator# 1263
Birmingham, Alabama, 35205
Site Reference ID/Investigator# 1683
Boston, Massachusetts, 02114
Site Reference ID/Investigator# 1259
Buckner 13075 PI, Alabama, 35233
Site Reference ID/Investigator# 1264
Chicago, Illinois, 60612
Site Reference ID/Investigator# 1265
Cincinnati, Ohio, 45219
Site Reference ID/Investigator# 90
Cleveland, Ohio, 44106
Site Reference ID/Investigator# 2434
Columbus, Ohio, 43212
Site Reference ID/Investigator# 87
Dallas, Texas, 75246-1613
Site Reference ID/Investigator# 122
Fresno, California, 93720
Site Reference ID/Investigator# 92
Fridley, Minnesota, 55432
Site Reference ID/Investigator# 1800
Goodlettsville, Tennessee, 37072
Site Reference ID/Investigator# 97
Greer, South Carolina, 29651
Site Reference ID/Investigator# 1323
Hershey, Pennsylvania, 17033
Site Reference ID/Investigator# 1279
Houston, Texas, 77030
Site Reference ID/Investigator# 1267
Indianapolis, Indiana, 46256
Site Reference ID/Investigator# 1671
Indianapolis, Indiana, 46260
Site Reference ID/Investigator# 1669
Irvine, California, 92697
Site Reference ID/Investigator# 96
Jacksonville, Florida, 32204
Site Reference ID/Investigator# 99
Johnston, Rhode Island, 02919
Site Reference ID/Investigator# 1260
Lake Oswego, Oregon, 97035
Site Reference ID/Investigator# 100
Little Rock, Arkansas, 72205
Site Reference ID/Investigator# 1269
Longmont, Colorado, 80501
Site Reference ID/Investigator# 1258
Louisville, Kentucky, 40202
Site Reference ID/Investigator# 1801
Maywood, Illinois, 60153
Site Reference ID/Investigator# 1262
Minneapolis, Minnesota, 55455
Site Reference ID/Investigator# 5199
Mt. Pleasant, South Carolina, 29464
Site Reference ID/Investigator# 1282
Nashville, Tennessee, 37215
Site Reference ID/Investigator# 2119
New Brunswick, New Jersey, 08903
Site Reference ID/Investigator# 1275
New Haven, Connecticut, 06511
Site Reference ID/Investigator# 1672
New York, New York, 10016
Site Reference ID/Investigator# 1797
New York, New York, 10025
Site Reference ID/Investigator# 95
New York, New York, 10029
Site Reference ID/Investigator# 1655
New York, New York, 10032
Site Reference ID/Investigator# 1674
Newnan, Georgia, 30263
Site Reference ID/Investigator# 123
Norfolk, Virginia, 23507
Site Reference ID/Investigator# 1285
Oceanside, California, 92056
Site Reference ID/Investigator# 1673
Omaha, Nebraska, 68131
Site Reference ID/Investigator# 1277
Philadelphia, Pennsylvania, 19103
Site Reference ID/Investigator# 2431
Pinellas Park, Florida, 33781
Site Reference ID/Investigator# 1667
Portland, Oregon, 97210
Site Reference ID/Investigator# 121
Portland, Oregon, 97223
Site Reference ID/Investigator# 1676
Providence, Rhode Island, 02903
Site Reference ID/Investigator# 1266
Raleigh, North Carolina, 27612
Site Reference ID/Investigator# 88
Rochester, New York, 14623
Site Reference ID/Investigator# 2079
Salt Lake City, Utah, 84132
Site Reference ID/Investigator# 1665
San Antonio, Texas, 78229
Site Reference ID/Investigator# 86
San Diego, California, 92123
Site Reference ID/Investigator# 1679
Santa Monica, California, 90404
Site Reference ID/Investigator# 2427
Scottsdale, Arizona, 85251
Site Reference ID/Investigator# 1653
Seattle, Washington, 98101
Site Reference ID/Investigator# 1281
Shreveport, Louisiana, 71103
Site Reference ID/Investigator# 1670
Snellville, Georgia, 30078
Site Reference ID/Investigator# 1273
South Miami, Florida, 33143
Site Reference ID/Investigator# 1681
Springfield, Illinois, 62702
Site Reference ID/Investigator# 1657
St Louis, Missouri, 63110
Site Reference ID/Investigator# 89
St Louis, Missouri, 63117
Site Reference ID/Investigator# 1677
Torrance, California, 90503
Site Reference ID/Investigator# 2433
Tucson, Arizona, 85710
Site Reference ID/Investigator# 1268
Tyler, Texas, 75703
Site Reference ID/Investigator# 2432
West Palm Beach, Florida, 33407
Site Reference ID/Investigator# 1256
Williamsville, New York, 14221
Site Reference ID/Investigator# 83
Worcester, Massachusetts, 01610
Canada17 sites
Site Reference ID/Investigator# 1629
Calgary, Alberta, T2S 3B3
Site Reference ID/Investigator#1641
Edmonton, Alberta, T5K 1X3
Site Reference ID/Investigator# 94
Halifax, Nova Scotia, B3H 1Z4
Site Reference ID/Investigator# 1640
Hamilton, Ontario, L8N 1V6
Site Reference ID/Investigator# 1636
London, Ontario, N5X 2P1
Site Reference ID/Investigator# 102
Montreal, Quebec, H2K 4L5
Site Reference ID/Investigator# 1637
Montreal, Quebec, H2K 4L5
Site Reference ID/Investigator# 101
Montreal, Quebec, H3H 1V4
Site Reference ID/Investigator# 1639
North Bay, Ontario, P1B 3Z7
Site Reference ID/Investigator# 1802
Québec, Quebec, G1V 4X7
Site Reference ID/Investigator# 1635
St. John's, Newfoundland and Labrador, A1B 4S8
Site Reference ID/Investigator# 120
St. John's, Newfoundland and Labrador, A1C 2H5
Site Reference ID/Investigator# 1633
Toronto, Ontario, M5V 2T3
Site Reference ID/Investigator# 104
Vancouver, British Columbia, V5Z 4E8
Site Reference ID/Investigator# 1631
Waterloo, Ontario, N2J 1C4
Site Reference ID/Investigator# 1647
Westmount, Quebec, H3Z 2S6
Site Reference ID/Investigator# 103
Windsor, Ontario, N8W 1E6
France4 sites
Site Reference ID/Investigator# 2553
Créteil, 94010
Site Reference ID/Investigator# 2191
Nice, 06200
Site Reference ID/Investigator# 2190
Paris, 75475
Site Reference ID/Investigator# 2189
Saint-Etienne, 42055
Germany4 sites
Site Reference ID/Investigator# 2198
Frankfurt, 60590
Site Reference ID/Investigator# 2543
Kiel, 24105
Site Reference ID/Investigator# 2188
Münster, 48149
Site Reference ID/Investigator# 2187
Tübingen, 72076
Austria3 sites
Site Reference ID/Investigator# 2181
Graz, 8036
Site Reference ID/Investigator# 2180
Innsbruck, A-6020
Site Reference ID/Investigator# 2176
Vienna, 1090
Spain3 sites
Site Reference ID/Investigator# 2182
Madrid, 28006
Site Reference ID/Investigator# 2185
Seville, 41009
Site Reference ID/Investigator# 2183
Valencia, 46014
Belgium2 sites
Site Reference ID/Investigator# 2554
Brussels, 1200
Site Reference ID/Investigator# 2179
Edegem, 2650
Poland2 sites
Site Reference ID/Investigator# 2178
Gdansk, 80-211
Site Reference ID/Investigator# 2177
Płock, 09-402
Puerto Rico2 sites
Site Reference ID/Investigator# 2194
Cagaus, 00725
Site Reference ID/Investigator# 5507
Carolina, 00985
About this study
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
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.
Read the detailed description
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.
- Conditions
- Psoriasis
- Being tested
- adalimumab
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adalimumabDrug
Also called ABT-D2E7, Humira
40 mg every other week or 40 mg every week by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab | Other | Not described Receives: Drug: adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With a Physician's Global Assessment of Clear or Minimal at 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.
Measured: Week 16 of Period R
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMay 2004
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,469 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Martin Okun, MD, PhD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00195676
- Sponsor's protocol ID
- M03-658
- Other IDs
- 2005-000095-41, 2005
- Status last verified
- Apr 2011
- First submitted
- 13 Sep 2005
- Last updated
- 13 Apr 2011
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Gordon K, Papp K, Poulin Y, Gu Y, Rozzo S, Sasso EH. Long-term efficacy and safety of adalimumab in patients with moderate to severe psoriasis treated continuously over 3 years: results from an open-label extension study for patients from REVEAL. J Am Acad Dermatol. 2012 Feb;66(2):241-51. doi: 10.1016/j.jaad.2010.12.005. Epub 2011 Jul 14.
PubMed 21752491Papp K, Crowley J, Ortonne JP, Leu J, Okun M, Gupta SR, Gu Y, Langley RG. Adalimumab for moderate to severe chronic plaque psoriasis: efficacy and safety of retreatment and disease recurrence following withdrawal from therapy. Br J Dermatol. 2011 Feb;164(2):434-41. doi: 10.1111/j.1365-2133.2010.10139.x.
PubMed 21083543
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00195676
- Acronym / sponsor ID
- M03-658
- Conditions
- Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,469 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Posted 19 Nov 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adalimumab | Other | Drug: adalimumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adalimumabAlso: ABT-D2E7, Humira40 mg every other week or 40 mg every week by subcutaneous injection | Drug | Adalimumab |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21752491Gordon K, Papp K, Poulin Y, Gu Y, Rozzo S, Sasso EH. Long-term efficacy and safety of adalimumab in patients with moderate to severe psoriasis treated continuously over 3 years: results from an open-label extension study for patients from REVEAL. J Am Acad Dermatol. 2012 Feb;66(2):241-51. doi: 10.1016/j.jaad.2010.12.005. Epub 2011 Jul 14.
- Derived from this study: PubMed 21083543Papp K, Crowley J, Ortonne JP, Leu J, Okun M, Gupta SR, Gu Y, Langley RG. Adalimumab for moderate to severe chronic plaque psoriasis: efficacy and safety of retreatment and disease recurrence following withdrawal from therapy. Br J Dermatol. 2011 Feb;164(2):434-41. doi: 10.1111/j.1365-2133.2010.10139.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Okun, MD, PhD study director
Abbott
104 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing adalimumab in people with Psoriasis, run by Abbott at 104 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 104 sites in United States, Canada, France, Germany, Austria and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00195676, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2011.