Chronic Plaque PsoriasisPhase 2NCT00245765

Efficacy Study of CDP870 in Subjects With Chronic Plaque Psoriasis Who Are Candidate for Systemic Therapy and/or Phototherapy/Photochemotherapy

A Phase 2 study testing Certolizumab Pegol in people with Chronic Plaque Psoriasis, run by UCB Pharma at 15 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A study to assess the safety and efficacy of 2 different doses of CDP870 versus placebo, administered during 12 weeks, to patients suffering from moderate to severe chronic plaque psoriasis, extended by a 12 to 24 week follow-up. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Plaque Psoriasis
What is being tested?: Certolizumab Pegol
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 176 participants
Where: 15 sitesin 2 countries
Study dates: Oct 2005to Nov 2006
Phase: Phase 2
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

Adult men and women > 18 years
Subjects with chronic plaque psoriasis stable for at least 3 months and moderate to severe for at least 6 months
Subjects with Psoriasis Area and Severity Index (PASI) ≥ 12 and Body Surface Area (BSA) ≥ 10 %
Subjects were candidates for systemic psoriasis therapy and/or phototherapy and/or photochemotherapy

Who cannot join

Subjects with an erythrodermic, guttate, palmar or plantar, generalized pustular form of psoriasis
A history of chronic infection, recent serious or life-threatening infection (within six months, including herpes zoster), or any current sign or symptom that may indicate an infection (e.g. fever, cough);
White blood cell counts less than 4000/mm^3 or more than 20000/mm^3
Suspected or diagnosed demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis)
Systemic Lupus
Non respect of adequate wash out periods for treatments that might have an impact on the disease
Any associated disease that could be impacted by the study treatment intake
Any other condition, which in the Investigator's judgment would make the subject unsuitable for inclusion in the study

Trial locations and contacts

15 sites in 2 countries.

Country

City, postcode or hospital

15 sites in 2 countries

Germany9 sites

Study site
Berlin
Study site
Bonn
Study site
Essen
Study site
Frankfurt
Study site
Göttingen
Study site
Hamburg
Study site
Kiel
Study site
Mainz
Study site
Münster

Other trials in Germany

France6 sites

Study site
Besançon
Study site
Créteil
Study site
Nice
Study site
Paris
Study site
Pierre-Bénite
Study site
Saint-Etienne

Other trials in France

About this study

Official title: Multicenter, Dose Response, Randomized, Double Blind, Parallel, Placebo Controlled Clinical Trial to Evaluate the Efficacy and the Safety of Subcutaneous CDP870 in Subjects Suffering From Moderate-to-severe Chronic Plaque Psoriasis Who Are Candidates for Systemic Therapy and/or Phototherapy and/or Photochemotherapy

Conditions: Chronic Plaque Psoriasis
Being tested: Certolizumab Pegol, Placebo
Keywords: chronic plaque psoriasis, anti TNFα, CDP870, Cimzia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Certolizumab PegolDrug
Also called Cimzia
- Pharmaceutical Form: solution for injection in pre-filled syringe
- Route of Administration: subcutaneous use
PlaceboOther
Matching Placebo to Certolizumab Pegol

Study groups in NCT00245765
Study group	Role	What they receive
Placebo	Placebo comparator	Subcutaneous injections of Placebo every 2 weeks Receives: Other: Placebo
Certolizumab Pegol 200 mg	Experimental	Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter Receives: Drug: Certolizumab Pegol
Certolizumab Pegol 400 mg	Experimental	Subcutaneous injections of 400 mg every 2 weeks Receives: Drug: Certolizumab Pegol

What is being measured

The primary outcome is the main question the study is designed to answer.

Achievement of Psoriasis Activity and Severity Index (PASI75) Response at Week 12
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
PASI75 response at Week 12 is defined as a decrease in PASI score at Week 12 from Baseline of at least 75 %.
Measured: Week 12
Achievement of a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12
The overall severity of the disease was evaluated using the following 6-point scale:
5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema
1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present)
Measured: Week 12

Secondary outcomes (9)

Time to Psoriasis Activity and Severity Index 50 (PASI50)
Time to PASI50 is defined as the time elapsed between the start of the Treatment Period (Week 0) and the first occurrence of PASI50 during the Treatment Period.
This variable is defined only for those patients who have achieved PASI75 at the end of the Treatment Period (Week 12).
Measured: During the 12-weeks Treatment Period
Time to Psoriasis Activity and Severity Index 75 (PASI75)
Time to PASI75 is defined as the time elapsed between the start of the Treatment Period (Week 0) and the first occurrence of PASI75 during the Treatment Period.
This variable is defined only for those patients who have achieved PASI75 at the end of the Treatment Period (Week 12).
Measured: During the 12-weeks Treatment Period
Time to Relapse
Time to relapse is defined as the time elapsed between the last dose and when maximal improvement in PASI from Baseline was reduced by > 50 %. This variable is defined only for those patients who have achieved PASI75 at the end of the Treatment Period (Week 12).
Measured: During the 12-weeks Treatment Period
Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
PASI50 response at Week 12 is defined as a decrease in PASI score at Week 12 from Baseline of at least 50 %.
Measured: Week 12
Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
PASI90 response at Week 12 is defined as a decrease in PASI score at Week 12 from Baseline of at least 90 %.
Measured: Week 12
Experience of a Rebound Effect Within 2 Months After Stopping Therapy
Rebound is defined as worsening of psoriasis over baseline value with more than 125 % or new pustular, erythrodermic or more inflammatory psoriasis within 2 months of stopping therapy.
Measured: Within 2 months of stopping therapy
Percent of Body Surface Area (BSA) Affected by Psoriasis at Week 12
Two methods were used for the evaluation of BSA:
1. The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
2. The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)
Measured: Week 12
Absolute Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Week 12
Two methods were used for the evaluation of BSA:
1. The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
2. The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Measured: Baseline up to Week 12
Time to Discontinuation From the Treatment Period Due to Lack of Efficacy or Worsening of Psoriasis
Measured: During the 12-week Treatment Period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2005Nov 2006

First posted28 Oct 2005 (estimated)
Study startOct 2005
Primary completionNov 2006
Study completionNov 2006

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 (9)Papers the sponsor has linked to this study.
Other trials for Chronic Plaque 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 176 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00245765
Sponsor's protocol ID: C87040
Other IDs: 2005-002141-39, 2005
Status last verified: Jan 2019
First submitted: 26 Oct 2005
Last updated: 3 May 2019
Results posted: Yes, on ClinicalTrials.gov

Publications

Ortonne JP, Tasset C, Reich K. Efficacy of certolizumab pegol, a PEGylated Fab' fragment of an anti-alpha monoclonal antibody, in patients previously exposed to biologicals: preliminary results of a randomised, placebo-controlled, phase II clinical trial in psoriasis. J.Eur.Acad.Dermatol.Venereol. 22[Suppl 1], 2007. Vienna, 16th Congress of the European Academy of Dermatology and Venereology (EADV), May 16-20, 2007.
Ortonne JP, Sterry W, Tasset C, Reich K. Safety and efficacy of subcutaneous certolizumab pegol, a new anti-TNF-alpha monoclonal antibody, in patients with moderate-to-severe chronic plaque psoriasis: preliminary results from a double-blind, placebo-controlled trial. J.Am.Acad.Dermatol. 56[Suppl 2], AB6. 2007. Washington, DC, 65th Annual Meeting of the American Academy of Dermatology (AAAD), February 2-7, 2007.
Reich K, Tasset C, Ortonne J. Efficacy and safety of certolizumab pegol, in patients with chronic plaque psoriasis: preliminary results of a randomized, double-blind, placebo-controlled trial. Ann.Rheum.Dis. 66[Suppl 2], 251. 2007. Barcelona, Annual European Congress of Rheumatology EULAR 2007, June 13-16, 2007.
Ortonne JP, Sterry W, Tasset C, Reich K. Certolizumab pegol, the first pegylated anti-TNF alpha, is effective and well tolerated in patients with moderate-to-severe chronic plaque psoriasis: preliminary data from a phase II study. J.Eur.Acad.Dermatol.Venereol. 21[Suppl 1], 26. 2007. Rhodes, Greece, 15th Congress of the European Academy of Dermatology and Venereology (EADV), October 4-8, 2006.
Ortonne JP, Sterry W, Coteur G, Keininger DL, Reich K. Improved health-related quality of life in psoriasis patients following 10 weeks' treatment with certolizumab pegol: data from a Phase II study. 2007. Buenos Aires, Argentina, 21st World Congress of Dermatology, October 1-5, 2007.
Reich K, Sterry W, Tasset C, Terpstra I, Ortonne JP. Efficacy and time to relapse with certolizumab pegol, the first pegylated anti-TNF alpha agent, in patients with moderate-to-severe chronic plaque psoriasis: Phase II study results. 2007. Buenos Aires, Argentina, 21st World Congress of Dermatology, October 1-5, 2007.
Ortonne JP, Reich K, Sterry W, Terpstra I. Safety and efficacy (PASI 90 and global evaluation) of subcutaneous certolizumab pegol in patients with moderate to severe chronic plaque psoriasis: Results from a double-blind, placebo-controlled trial. J.Am.Acad.Dermatol. 58[Suppl 2], AB4. 2008. San Antonio, 66th Annual Meeting of the American Academy of Dermatology (AAD), February 1-5, 2008.
Ortonne JP, Reich K, Keininger DL. Certolizumab pegol improved health-related quality of life in patients with psoriasis: Data from a phase II study. J.Am.Acad.Dermatol. 58[Suppl 2], AB121. 2008. San Antonio, 66th Annual Meeting of the American Academy of Dermatology (AAD), February 1-5, 2008.
Reich K, Ortonne JP, Gottlieb AB, Terpstra IJ, Coteur G, Tasset C, Mease P. Successful treatment of moderate to severe plaque psoriasis with the PEGylated Fab' certolizumab pegol: results of a phase II randomized, placebo-controlled trial with a re-treatment extension. Br J Dermatol. 2012 Jul;167(1):180-90. doi: 10.1111/j.1365-2133.2012.10941.x. Epub 2012 Jun 11.
PubMed 22413944

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants
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RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
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RecruitingPhase 4
An Open Label Trial to Evaluate Efficacy and Safety of Roflumilast 0.3% Cream for Chronic Plaque and Nail Psoriasis
Chronic Plaque Psoriasis, Nail Psoriasis
RecruitingPhase 2
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RecruitingObservational study
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All Chronic Plaque Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter, Dose Response, Randomized, Double Blind, Parallel, Placebo Controlled Clinical Trial to Evaluate the Efficacy and the Safety of Subcutaneous CDP870 in Subjects Suffering From Moderate-to-severe Chronic Plaque Psoriasis Who Are Candidates for Systemic Therapy and/or Phototherapy and/or Photochemotherapy
ClinicalTrials.gov ID: NCT00245765
Acronym / sponsor ID: C87040
Conditions: Chronic Plaque Psoriasis
Keywords: chronic plaque psoriasis, anti TNFα, CDP870, Cimzia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 176 participants (actual)
Lead sponsor: UCB PharmaIndustry (pharma, biotech, devices)
Study start: Oct 2005
Primary completion: Nov 2006 (actual)
Study completion: Nov 2006 (actual)
First posted: 28 Oct 2005 (estimated)
Results: Posted 3 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Other: PlaceboSubcutaneous injections of Placebo every 2 weeks
Certolizumab Pegol 200 mg	Experimental	Drug: Certolizumab PegolSubcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter
Certolizumab Pegol 400 mg	Experimental	Drug: Certolizumab PegolSubcutaneous injections of 400 mg every 2 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Adult men and women > 18 years
Subjects with chronic plaque psoriasis stable for at least 3 months and moderate to severe for at least 6 months
Subjects with Psoriasis Area and Severity Index (PASI) ≥ 12 and Body Surface Area (BSA) ≥ 10 %
Subjects were candidates for systemic psoriasis therapy and/or phototherapy and/or photochemotherapy

Key exclusion criteria (8 listed)

Subjects with an erythrodermic, guttate, palmar or plantar, generalized pustular form of psoriasis
A history of chronic infection, recent serious or life-threatening infection (within six months, including herpes zoster), or any current sign or symptom that may indicate an infection (e.g. fever, cough);
White blood cell counts less than 4000/mm^3 or more than 20000/mm^3
Suspected or diagnosed demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis)
Systemic Lupus

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
Certolizumab PegolAlso: Cimzia* Pharmaceutical Form: solution for injection in pre-filled syringe * Route of Administration: subcutaneous use	Drug	Certolizumab Pegol 200 mg, Certolizumab Pegol 400 mg
PlaceboMatching Placebo to Certolizumab Pegol	Other	Placebo

Primary outcome

Achievement of Psoriasis Activity and Severity Index (PASI75) Response at Week 12
Time frame: Week 12
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities. PASI75 response at Week 12 is defined as a decrease in PASI score at Week 12 from Baseline of at least 75 %.
Achievement of a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12
Time frame: Week 12
The overall severity of the disease was evaluated using the following 6-point scale: 5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema 1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present)

9 secondary outcomes

Time to Psoriasis Activity and Severity Index 50 (PASI50)
Time frame: During the 12-weeks Treatment Period
Time to Psoriasis Activity and Severity Index 75 (PASI75)
Time frame: During the 12-weeks Treatment Period
Time to Relapse
Time frame: During the 12-weeks Treatment Period
Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12
Time frame: Week 12
Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12
Time frame: Week 12
Experience of a Rebound Effect Within 2 Months After Stopping Therapy
Time frame: Within 2 months of stopping therapy
Percent of Body Surface Area (BSA) Affected by Psoriasis at Week 12
Time frame: Week 12
Absolute Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Week 12
Time frame: Baseline up to Week 12
Time to Discontinuation From the Treatment Period Due to Lack of Efficacy or Worsening of Psoriasis
Time frame: During the 12-week Treatment Period

Results and safety

Results posted to the registry on 3 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo (ITT)	59	27
Certolizumab Pegol 200 mg (ITT)	59	45
Certolizumab Pegol 400 mg (ITT)	58	50

Primary outcome: Achievement of Psoriasis Activity and Severity Index (PASI75) Response at Week 12

Time frame: Week 12. Number. Unit: percentage of subjects

Measure	Placebo (ITT) n = 59	Certolizumab Pegol 200 mg (ITT) n = 59	Certolizumab Pegol 400 mg (ITT) n = 58
Value	6.8	74.6	82.8

Placebo (ITT) vs Certolizumab Pegol 200 mg (ITT): Odds Ratio (OR): 40.2 (95% CI 13.7 to 150.3), p <0.001, Regression, Logistic
Placebo (ITT) vs Certolizumab Pegol 400 mg (ITT): Odds Ratio (OR): 73.4 (95% CI 23.5 to 292.6), p <0.001, Regression, Logistic

Population analysed: Intention-To-Treat (ITT) population consisting of all randomized subjects.

Primary outcome: Achievement of a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12

Time frame: Week 12. Number. Unit: percentage of subjects

Measure	Placebo (ITT) n = 59	Certolizumab Pegol 200 mg (ITT) n = 59	Certolizumab Pegol 400 mg (ITT) n = 58
Value	1.7	52.5	72.4

Placebo (ITT) vs Certolizumab Pegol 200 mg (ITT): Odds Ratio (OR): 64.1 (95% CI 12.7 to 1169.1), p <0.001, Regression, Logistic
Placebo (ITT) vs Certolizumab Pegol 400 mg (ITT): Odds Ratio (OR): 162.6 (95% CI 31.4 to 2999.2), p <0.001, Regression, Logistic

Population analysed: Intention-To-Treat (ITT) population consisting of all randomized subjects.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected from Baseline (Week 0) over the 12-weeks Treatment Period until the end of the Follow-up Period (up to 36 weeks).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (SS)	1 of 58 (1.7%)	34 of 58 (58.6%)	0 of 58
Certolizumab Pegol 200 mg (SS)	2 of 60 (3.3%)	32 of 60 (53.3%)	0 of 60
Certolizumab Pegol 400 mg (SS)	5 of 57 (8.8%)	27 of 57 (47.4%)	0 of 57

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publicationOrtonne JP, Tasset C, Reich K. Efficacy of certolizumab pegol, a PEGylated Fab' fragment of an anti-alpha monoclonal antibody, in patients previously exposed to biologicals: preliminary results of a randomised, placebo-controlled, phase II clinical trial in psoriasis. J.Eur.Acad.Dermatol.Venereol. 22[Suppl 1], 2007. Vienna, 16th Congress of the European Academy of Dermatology and Venereology (EADV), May 16-20, 2007.
Results publicationOrtonne JP, Sterry W, Tasset C, Reich K. Safety and efficacy of subcutaneous certolizumab pegol, a new anti-TNF-alpha monoclonal antibody, in patients with moderate-to-severe chronic plaque psoriasis: preliminary results from a double-blind, placebo-controlled trial. J.Am.Acad.Dermatol. 56[Suppl 2], AB6. 2007. Washington, DC, 65th Annual Meeting of the American Academy of Dermatology (AAAD), February 2-7, 2007.
Results publicationReich K, Tasset C, Ortonne J. Efficacy and safety of certolizumab pegol, in patients with chronic plaque psoriasis: preliminary results of a randomized, double-blind, placebo-controlled trial. Ann.Rheum.Dis. 66[Suppl 2], 251. 2007. Barcelona, Annual European Congress of Rheumatology EULAR 2007, June 13-16, 2007.
Results publicationOrtonne JP, Sterry W, Tasset C, Reich K. Certolizumab pegol, the first pegylated anti-TNF alpha, is effective and well tolerated in patients with moderate-to-severe chronic plaque psoriasis: preliminary data from a phase II study. J.Eur.Acad.Dermatol.Venereol. 21[Suppl 1], 26. 2007. Rhodes, Greece, 15th Congress of the European Academy of Dermatology and Venereology (EADV), October 4-8, 2006.
Results publicationOrtonne JP, Sterry W, Coteur G, Keininger DL, Reich K. Improved health-related quality of life in psoriasis patients following 10 weeks' treatment with certolizumab pegol: data from a Phase II study. 2007. Buenos Aires, Argentina, 21st World Congress of Dermatology, October 1-5, 2007.
Results publicationReich K, Sterry W, Tasset C, Terpstra I, Ortonne JP. Efficacy and time to relapse with certolizumab pegol, the first pegylated anti-TNF alpha agent, in patients with moderate-to-severe chronic plaque psoriasis: Phase II study results. 2007. Buenos Aires, Argentina, 21st World Congress of Dermatology, October 1-5, 2007.
Results publicationOrtonne JP, Reich K, Sterry W, Terpstra I. Safety and efficacy (PASI 90 and global evaluation) of subcutaneous certolizumab pegol in patients with moderate to severe chronic plaque psoriasis: Results from a double-blind, placebo-controlled trial. J.Am.Acad.Dermatol. 58[Suppl 2], AB4. 2008. San Antonio, 66th Annual Meeting of the American Academy of Dermatology (AAD), February 1-5, 2008.
Results publicationOrtonne JP, Reich K, Keininger DL. Certolizumab pegol improved health-related quality of life in patients with psoriasis: Data from a phase II study. J.Am.Acad.Dermatol. 58[Suppl 2], AB121. 2008. San Antonio, 66th Annual Meeting of the American Academy of Dermatology (AAD), February 1-5, 2008.
Results publication: PubMed 22413944Reich K, Ortonne JP, Gottlieb AB, Terpstra IJ, Coteur G, Tasset C, Mease P. Successful treatment of moderate to severe plaque psoriasis with the PEGylated Fab' certolizumab pegol: results of a phase II randomized, placebo-controlled trial with a re-treatment extension. Br J Dermatol. 2012 Jul;167(1):180-90. doi: 10.1111/j.1365-2133.2012.10941.x. Epub 2012 Jun 11.

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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.

UCB Clinical Trial Call Center study director

UCB Pharma

15 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Certolizumab Pegol in people with Chronic Plaque Psoriasis, run by UCB Pharma at 15 sites in 2 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 4 inclusion and 8 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 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Germany, France. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 3 May 2019). 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?

Achievement of Psoriasis Activity and Severity Index (PASI75) Response at Week 12 (time frame: Week 12). The study lists 2 primary outcomes in all. 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 NCT00245765, which also lists 9 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 3 May 2019.