Open-label Study to Assess the Safety and Efficacy of CDP6038 in Patients Who Completed RA0056
Status: | Completed |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/14/2017 |
Start Date: | March 2011 |
End Date: | August 2013 |
A Phase 2, Multicenter, Open-Label, Follow-up Study to Assess the Long-Term Safety and Efficacy of CDP6038 Administered Subcutaneously to Subjects With Active Rheumatoid Arthritis Who Completed Study RA0056
The purpose of this study is to evaluate the long term safety and tolerability of CDP6038
treatment in adult subjects with active rheumatoid arthritis (RA) who completed RA0056.
treatment in adult subjects with active rheumatoid arthritis (RA) who completed RA0056.
Inclusion Criteria:
- Subject completed the RA0056 study (Week 12 Visit)
- Subject must have maintained their stable dose (and route) of methotrexate (MTX)
between 12.5 to 25mg/week in RA0056, and plan to maintain this same dose and route of
administration for at least 12 weeks
- 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
Exclusion Criteria:
- Subject has an ongoing serious adverse event from the RA0056 study
- Female subject of childbearing potential has a positive pregnancy test or plans to
become pregnant during the study or within 6 months (24 weeks) following their last
dose of study medication
- Subject has evidence of active or latent tuberculosis
- Subject is receiving any biologic response modifier or synthetic disease-modifying
antirheumatic drug other than MTX
- Subject has an alcohol consumption of more than 1 unit per weekday. One unit equals 1
glass of beer or lager (~330mL), a glass of wine (125mL), or a measure of spirits/hard
liquor (25mL)
- Subject with any other condition in RA0056 (eg, clinically significant laboratory
values, frequent adverse events) which in the Investigator's or Sponsor's judgment
would make the subject unsuitable for inclusion in the study
We found this trial at
47
sites
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