A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THE TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - ND

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-002066-35-IT
• Date of registration: 07/09/2007
• Prospective Registration: Yes
• Primary sponsor: PFIZER
• Public title: A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THE TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - ND
• Scientific title: A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED ACTIVE COMPARATOR, MULTICENTER STUDY TO COMPARE 5 DOSE REGIMENS OF CP-690,550 AND ADALIMUMAB VERSUS PLACEBO, ADMINISTERED FOR 6 MONTHS IN THE TREATMENT OF SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS - ND
• Date of first enrolment: 13/02/2008
• Target sample size: 350
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-002066-35
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: Other: no

Countries of recruitment

Bulgaria, Czech Republic, Germany, Greece, Hungary, Italy

Key inclusion & exclusion criteria

Inclusion criteria:
1. Evidence of a signed and dated informed consent document(s) indicating that the subject has been informed of all pertinent aspects of the study. 2. Subjects must be at least 18 years of age. 3. If the subject is a sexually active woman of childbearing potential, she and any male partner are required to simultaneously use 2 effective contraceptive methods, from the list of effective contraceptives found in Section 4.4 4. Non-vasectomized men must be willing to abstain from sexual intercourse or willing to use a condom in addition to having their female partner use another form of contraception such as an IUD, barrier method with spermicide, oral contraceptive, injectable progesterone, sub-dermal implant, or a tubal ligation, if the woman could become pregnant from the time of the first dose of study medication until completion of follow-up procedures. 5. The subject has a diagnosis of RA based upon the American College of Rheumatology (ACR; formerly American Rheumatism Association) 1987 Revised Criteria5, ie, fulfilling at least 4 of the following 7 criteria for at least 6 consecutive months preceding randomization: a. morning stiffness in and around any joint for more than 1 hour; b. soft tissue swelling of 3 or more joint areas; c. swelling of the proximal interphalangeal (PIP), metacarpophalangeal (MCP) or wrist joints; d. symmetrical joint swelling; e. rheumatoid nodules; f. serum rheumatoid factor positive; g. radiographic erosions and/or periarticular osteopenia in hand and/or wrist joints. 6. The subject has active disease at both Screening and Baseline, 7. The subject meets ACR 1991 Revised Criteria for Global Functional Status in RA, Class I, II or III (Appendix 1). 7. Subjects must have failed an adequate study of therapy with at least 1 DMARD due to lack of efficacy or toxicity.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Subjects who discontinued any previous TNFi therapy for either lack of efficacy or adverse events. Subjects who previously received adalimumab therapy for any reason are not allowed in the study. 2. Subjects with evidence of hematopoietic disorders. 3. Estimated GFR

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

CP-690,550 is being developed as a disease-modifying antirheumatic drug (DMARD) for the treatment of rheumatoid arthritis (RA).
MedDRA version: 6.1 Level: PT Classification code 10039073

Intervention(s)

Product Name: CP-690,550
Pharmaceutical Form: Tablet
CAS Number: 540737-29-9
Current Sponsor code: CP-690,550
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Name: CP-690,550
Pharmaceutical Form: Tablet
CAS Number: 540737-29-9
Current Sponsor code: CP-690,550
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Trade Name: Humira
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Adalimumab
Current Sponsor code: Adalimumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Main Objective: The primary objective is to characterize the dose-response of CP-690-550 over the range of 1-15 mg BID on ACR 20 response criteria at 12 weeks.

Secondary Objective: 1. To examine the durability of the response of 5 dose levels of oral CP-690,550 (15 mg, 10 mg, 5 mg, 3 mg and 1 mg BID) versus placebo, administered over 6 months for the treatment of the signs and symptoms in subjects with active RA. 2. To compare the efficacy of adalimumab 40 mg subcutaneous (sc) every other week (QOW), administered over 12 weeks, versus placebo for the treatment of signs and symptoms in subjects with active RA. 3. To evaluate the safety and tolerability of 5 dose levels of oral CP-690,550 (15 mg, 10 mg, 5 mg, 3 mg and 1 mg BID) administered over 6 months versus placebo to subjects with active RA. 4. To evaluate the safety of switching from adalimumab to CP-690,550. 5. To evaluate health status and functional status in these subjects. 6. To characterize the relationship among doses, plasma concentrations of CP-690,550 and efficacy and safety outcome measures in subject with active RA.

Primary end point(s): American College of Rheumatology 20 (ACR 20) responder rate at the Week 12 visit.

Secondary ID(s)

2007-002066-35-HU

A3921035