Open-label study to assess the safety and efficacy of CDP6038 in patients who completed RA0056

Conditions: Rheumatoid Arthritis
MedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2010-022224-77-GB

Lead Sponsor: CB Biosciences Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 190

Inclusion Criteria

Subjects completing RA0056 are eligible to participate in this study, if all of the following criteria are met:
1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject.
2. Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule or medication intake according to the judgment of the Investigator.
3. Subject completed the RA0056 study (Week 12 Visit) and weighed =40kg at that visit.
4. Subject should have maintained their stable dose (and route) of MTX between 12.5 to 25mg/week in RA0056, and should plan to maintain this same dose and route of administration for at least 12 weeks. For safety and tolerability reasons, 1 single-dose reduction in MTX up to 5mg/week is allowed during the first 12 weeks of the study. For dose reductions after Week 12, see Section 7.8.4. Further reduction in MTX dose may be allowed upon discussion with the Sponsor. Subjects may have been dosed with 10 to =12.5mg weekly if they have documented reasons for toxicity. Subjects must be willing to initiate, or continue on, folate supplementation while taking MTX during the study (see Section 7.8).
5. Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (either oral/parenteral/implantable hormonal contraceptives, intrauterine device, or barrier and spermicide). Abstinence is not considered an acceptable method of contraception for this study. Female subjects of childbearing potential must agree to use 2 methods of adequate contraception during the study and for 6 months (24 weeks) after their last CDP6038 dose. Male subjects must agree to ensure that they or their female partner(s) use adequate contraception during the study and for 12 weeks after the subject receives their last dose
of CDP6038.
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

Subjects are not permitted to enroll in the study if any of the following criteria is met:
1. Subject has an ongoing SAE from the RA0056 study.
2. Female subject of childbearing potential has a positive pregnancy test at Week 12 in RA0056 or plans to become pregnant during the study or within 6 months (24 weeks) following their last dose of IMP.
3. Subject has evidence of active or latent tuberculosis (TB) based on the Investigator’s medical judgement.
4. Subject is receiving any biologic response modifier or synthetic DMARD other than MTX.
5. Subject has an alcohol consumption of more than 1 unit per day. One unit equals 1 glass of beer or lager (~330mL), a glass of wine (125mL), or a measure of spirits/hard liquor (25mL).
6. This criterion was deleted as part of Protocol Amendment 3.
7. Subject with any other condition in RA0056 (eg, clinically significant laboratory values, frequent AEs or SAEs, or infection SAEs) which in the Investigator’s or Sponsor’s judgment would make the subject unsuitable for inclusion in the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to assess the long-term safety of CDP6038 dosed at 120mg q2w while treating the signs and symptoms of active RA in subjects who have previously failed TNFa blocker therapy.;Secondary Objective: The secondary objectives are to evaluate the long-term efficacy of CDP6038, its plasma levels, and immunogenic profile.<br><br>;Primary end point(s): Safety variables<br>• AEs<br>• Vital signs<br>• Chest x-rays<br>• Electrocardiograms (ECG)<br>• Laboratory parameters<br>;Timepoint(s) of evaluation of this end point: AEs – assessed every 2 weeks throughout the study<br>Vital signs – assessed every 2 weeks throughout the study<br>Chest x-rays – assessed at Week 48 and completion<br>Electrocardiograms (ECG) – assessed at Weeks 4, 12, 24, 48 and completion<br>Laboratory parameters – assessed at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and q8w thereafter to study completion<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Efficacy variables include:<br>Change from Baseline (Week 0 of RA0056) in the DAS28(CRP) <br>ACR20/50/70 improvement criteria response rates (from Baseline at Week 0 of RA0056) Percentage of subjects with DAS28(CRP) <2.6 and with DAS28(CRP) =3.2 <br>Change from Baseline (Week 0 of RA0056) in CDAI and SDAI PK and antibodies:<br>;Timepoint(s) of evaluation of this end point: Efficacy variables include:<br>Change from Baseline (Week 0 of RA0056) in the DAS28(CRP) at Weeks 12, 24, and 48<br>ACR20/50/70 improvement criteria response rates (from Baseline at Week 0 of RA0056) at Weeks 24, and 48<br>Percentage of subjects with DAS28(CRP) <2.6 and with DAS28(CRP) =3.2 at Weeks 12, 24, and 48<br>Change from Baseline (Week 0 of RA0056) in CDAI and SDAI at Week 48<br><br>PK and antibodies:<br>Weeks 4, 8, 12, 16, 24, 32, 48, and 72<br>

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