Study in Rheumatoid Arthritis for Subjects Who Completed Preceding Study M13-390 With Adalimumab
This study is currently recruiting participants.
Verified March 2013 by AbbVie
Sponsor:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01752855
First received: December 17, 2012
Last updated: March 15, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Phase 2b,open label, multicenter study in rheumatoid arthritis for subjects who completed the previous M13-390 study.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Biological: adalimumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects Who Completed Preceding Study M13-390 With Adalimumab |
Resource links provided by NLM:
MedlinePlus related topics:
Rheumatoid Arthritis
Drug Information available for:
Adalimumab
U.S. FDA Resources
Further study details as provided by AbbVie:
Primary Outcome Measures:
- Change from baseline in disease activity score (DAS28) [CRP] with baseline being Study M13-390 Week 0 Visit. [ Time Frame: Week 12 and Week 24 ] [ Designated as safety issue: No ]
- Response defined by American College of Rheumatology (ACR) 20/50/70/90/100 criteria with baseline being Study M13-390 Week 0 Visit. [ Time Frame: Week 12 and Week 24 ] [ Designated as safety issue: No ]
- Change from baseline in Health assessment Questionnaire (HAQ-DI) with baseline being Study M13-390 Week 0 Visit. [ Time Frame: Week 12 and Week 24 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: adalimumab
concentration 40mg/0.4 mL
|
Biological: adalimumab
concentration 40mg/0.4mL
Other Name: Humira
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject has completed the preceding Study M13-390 for rheumatoid arthritis and has not developed any discontinuation criteria from that study.
If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy) or is of childbearing potential and is practicing an approved method of birth control throughout the study and for 150 days after last dose of study drug. Examples of approved methods of birth control include the following (see local informed consent for more detail):
- Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD);
- Hormonal contraceptives for 90 days prior to study drug administration;
- A vasectomized partner;
- Subjects must be able and willing to self-administer subcutaneous (SC) injections or have a qualified person available to administer SC injections.
- Subject is judged to be in good general health as determined by the Principal Investigator based upon the results of medical history, physical examination, laboratory profile performed at Baseline.
- Subjects must be able and willing to provide written informed consent and to comply with the requirements of this study protocol.
Exclusion Criteria:
- Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to the Baseline Visit or oral anti-infectives within 14 days prior to the Baseline Visit.
- Subject currently uses or plans to use anti-retroviral therapy at any time during the study.
- Subject plans to use any live vaccine during the study.
- Positive pregnancy test at Baseline (Week 0).
- Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01752855
Contacts
| Contact: Melissa Ropiak, BS | 847-937-0887 | melissa.ropiak@abbvie.com |
| Contact: Harshit Mehta | 847-937-5903 | harshit.mehta@abbvie.com |
Locations
| United States, Arizona | |
| Site Reference ID/Investigator# 92113 | Recruiting |
| Mesa, Arizona, United States, 85202 | |
| Principal Investigator: Site Reference ID/Investigator# 92113 | |
| United States, California | |
| Site Reference ID/Investigator# 92118 | Recruiting |
| Hemet, California, United States, 92543 | |
| Principal Investigator: Site Reference ID/Investigator# 92118 | |
| United States, Kansas | |
| Site Reference ID/Investigator# 92117 | Recruiting |
| Wichita, Kansas, United States, 67203 | |
| Principal Investigator: Site Reference ID/Investigator# 92117 | |
| United States, New Jersey | |
| Site Reference ID/Investigator# 92115 | Recruiting |
| Clifton, New Jersey, United States, 07012 | |
| Principal Investigator: Site Reference ID/Investigator# 92115 | |
| United States, Pennsylvania | |
| Site Reference ID/Investigator# 92116 | Recruiting |
| Philadelphia, Pennsylvania, United States, 19152 | |
| Principal Investigator: Site Reference ID/Investigator# 92116 | |
| United States, South Carolina | |
| Site Reference ID/Investigator# 92114 | Recruiting |
| Charleston, South Carolina, United States, 29406 | |
| Principal Investigator: Site Reference ID/Investigator# 92114 | |
| Puerto Rico | |
| Site Reference ID/Investigator# 92074 | Recruiting |
| Vega Baja, Puerto Rico, 00693 | |
| Principal Investigator: Site Reference ID/Investigator# 92074 | |
| Slovakia | |
| Site Reference ID/Investigator# 92096 | Recruiting |
| Banska Bystrica, Slovakia, 97405 | |
| Principal Investigator: Site Reference ID/Investigator# 92096 | |
| Site Reference ID/Investigator# 92097 | Recruiting |
| Senica, Slovakia, 905 01 | |
| Principal Investigator: Site Reference ID/Investigator# 92097 | |
| Site Reference ID/Investigator# 92098 | Recruiting |
| Zilina, Slovakia, 010 01 | |
| Principal Investigator: Site Reference ID/Investigator# 92098 | |
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
| Study Director: | Uday Arulmani, MD | AbbVie |
More Information
Additional Information:
No publications provided
| Responsible Party: | AbbVie ( AbbVie (prior sponsor, Abbott) ) |
| ClinicalTrials.gov Identifier: | NCT01752855 History of Changes |
| Other Study ID Numbers: | M13-692, 2012-003881-42 |
| Study First Received: | December 17, 2012 |
| Last Updated: | March 15, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AbbVie:
|
Rheumatoid Arthritis |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases |
Immune System Diseases Adalimumab Antirheumatic Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 16, 2013