Clinical Trials Register

Summary
EudraCT Number:	2007-000828-40
Sponsor's Protocol Code Number:	C87076
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2008-07-14
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2007-000828-40

A.3

Full title of the trial

A Phase IIIB, multi-centre, double-blind randomized, placebo-controlled, parallel group 52-week study to evaluate safety and efficacy of the PEGylated anti-TNFα Fab′ fragment, certolizumab pegol, administered concomitantly with stable-dose DMARDs in patients with moderate to low disease activity rheumatoid arthritis

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

C87076

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	UCB S.A. (Casa Madre)
B.1.3.4	Country	Belgium
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	certolizumab pegol
D.3.2	Product code	CDP870
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Certolizumab pegol
D.3.9.1	CAS number	428863-50-7
D.3.9.2	Current sponsor code	CDP870
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	Non Applicabile

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Rheumatoid arthritis with moderate to low disease activity

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	PT
E.1.2	Classification code	10039073
E.1.2	Term	Rheumatoid arthritis

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To assess the clinical efficacy of certolizumab pegol as an add-on therapy in demonstrating clinical remission at both Week 20 and Week 24 (defined as Clinical Disease Activity Index [CDAI] of ≤ 2.8).

E.2.2

Secondary objectives of the trial

To compare the efficacy of 2 treatment arms in Achievement of clinical remission at W20 and W24 (defined as 28- joint count [DAS28-ESR] of < 2.6) Achievement of clinical remission at W20 and W24 (defined as [SDAI] of ≤ 3.3) Maintenance of remission between W24 and W52 (based on CDAI, SDAI and DAS28) Reduction of signs and symptoms of the disease at W24 as measured by ACR criteria Improvement in patient’s physical function as measured by the Health Assessment Questionnaire Disability Index at W24 Improvement in patient’s Health-Related Quality of Life as measured by the Short Form 36 - items Health Survey (SF-36) Physical and Mental Component Summary scores and SF-36 domains at W24 Relief in patient's pain, fatigue and disease activity as measured by Patient’s Assessment of Arthritis Pain-Visual Analogue Scale (VAS), Fatigue Assessment of Disease Activity -VAS at Week 24 Safety: To evaluate thetolerability and safety of certolizumab pegol therapy

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patients must be at least 18 years old at the screening visit. 2. Female patients must be either postmenopausal for at least one year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (i.e. either oral/parenteral/implantable hormonal contraceptives, intrauterine device or barrier and spermicide). Abstinence only is not an acceptable method. Patients must agree to use adequate contraception during the study and for 12 weeks after the last dose of certolizumab pegol. 3. Patients must have a diagnosis of adult–onset RA (of at least six months duration but not longer than ten years) as defined by the 1987 American College of Rheumatology classification criteria. 4. Patients must have moderate to low disease activity as defined by all of the following: CDAI > 6 and ≤ 16 at Screening and Baseline ≥ 2 tender joints (28 joint count) at Screening and Baseline ≥ 2 swollen joints (28 joint count) at Screening and Baseline fulfilling 1 of the following 2 criteria at Screening: ≥28 mm/hour ESR (Westergren), or CRP >10 mg/L 5. Patients must have received combination or mono DMARD therapy ((i.e., Sulfasalazine ≤ 3g/day; Leflunomide ≤ 20mg/day; Hydroxychloroquine ≤ 400mg/day; MTX ≤ 25mg/week) for at least six months prior to the Baseline visit. The dose and route of administration of the DMARD therapy must have been stable for at least 2 months prior to the baseline visit. 6. Patients must be able to understand the information provided to them and to give written Informed Consent. 7. Patients must be able and willing to comply with the requirements of the study protocol.

E.4

Principal exclusion criteria

Patients must not have a diagnosis of any other inflammatory arthritis (e.g., psoriatic arthritis, ankylosing spondylitis or connective tissue disease). 2. Patients must not have a secondary, non–inflammatory type of arthritis (e.g. osteoarthritis or fibromyalgia) that in the Investigator’s opinion is symptomatic enough to interfere with evaluation of the effect of study drug on the patient’s primary diagnosis of RA. 3. Patients must not have a history of an infected joint prosthesis at any time with that prosthesis still in situ. 4. Patients must be free of prohibited medication as detailed in the table on page 45. 5. Patients must not have received any previous biological therapy for RA. 6. Patients must not have received any experimental non–biological therapy, within or outside a clinical trial in the three months prior to Baseline visit. Medical History Exclusion: 7. Female patients who are breast feeding, pregnant, or plan to become pregnant during the trial or for three months following last dose of study drug. 8. Patients with a history of chronic infection (more than 4 episodes requiring antibiotics/antivirals during the preceding year), recent serious or life–threatening infection within 6 months (including herpes zoster), or any current sign or symptom that may indicate an infection. 9. Patients with active TB (or history of active TB) or positive chest X–ray for TB or positive (defined as induration of ≥ 5mm) PPD skin test or patients having close contact with an individual with active TB. Patients having a PPD skin test greater or equal to 5 mm can enter the study, provided that active TB is excluded and provided that they are adequately treated for latent tuberculosis (e.g., isonicotinic acid hydrazide [INH therapy] for 9 months [with vitamin B6]) and provided that treatment is initiated at least 1 month prior to first administration of certolizumab pegol. For Germany, only patients having a chest X-Ray performed in their usual practice within 3 months before baseline can be included, waiting for the approval of the Radiation Board. 10. Patients at a high risk of infection (e.g. leg ulcers, indwelling urinary catheter andpersistent or recurrent chest infections and patients who are permanently bed ridden or wheelchair bound). 11. Patients with a history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease at any time. 12. Patients with known concurrent acute or chronic viral hepatitis B or C. 13. Patients with known human immunodeficiency virus (HIV) infection. 14. Patients receiving any vaccination (live or attenuated) within eight weeks prior to Baseline. (However, influenza and pneumococcal vaccines are allowed) 15. Concurrent malignancy or a history of malignancy (other than carcinoma of the cervix or basal cell carcinoma successfully treated more than five years prior to screening). 16. Patients with a history of blood dyscrasias. 17. Patients with a current or recent history, as determined by the Investigator, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease. 18. Patients with class III or IV congestive heart failure. New York Heart Association (NYHA) 1964.

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy variable is the proportion of subjects in CDAI remission (CDAI ≤ 2.8) at both Week 20 and Week 24 visits.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

Yes

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

La fine dello studio e' definita come la data dell'ultima visita (Week 62) dell'ultimo paziente.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.3

Elderly (>=65 years)

Yes

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-07-14.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Information not present in EudraCT

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

170

F.4.2.2

In the whole clinical trial

170

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Studio in aperto previsto per quei pazienti che non hanno raggiunto la remissione di malattia alla settimana 24 o che presentino una riacutizzazione la settimana 24 e la settimana 52.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2008-03-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2008-05-15

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2010-12-10

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