A Pilot Study of the Feasibility of Discontinuation of Adalimumab in Stable Rheumatoid Arthritis Patients in Clinical Remission (ADMIRE)
This study has been completed.
Sponsor:
AbbVie (prior sponsor, Abbott)
Collaborator:
Pharma Consulting Group AB
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00808509
First received: December 12, 2008
Last updated: January 2, 2013
Last verified: January 2013
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Purpose
Rheumatoid arthritis is a chronic disease. Treatment with anti-rheumatic drugs, including TNF-blocking agents, are commonly used. Once started, these drugs are usually continued indefinitely. Information, concerning the possibility to discontinue anti-TNF therapy in RA patients who are in remission (i.e. no significant remaining disease activity) is limited.The purpose of this pilot study is to investigate if it is possible to stop therapy of adalimumab (a TNF-blocker) in patients with established RA in stable remission after treatment with adalimumab in combination with methotrexate.
| Condition | Intervention | Phase |
|---|---|---|
|
Arthritis, Rheumatoid |
Biological: adalimumab Drug: methotrexate |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | A Pilot Study of the Feasibility of Discontinuation of Adalimumab in Stable RA Patients in Clinical Remission |
Resource links provided by NLM:
Further study details as provided by AbbVie:
Primary Outcome Measures:
- The proportions of RA patients in remission, defined as DAS28<2.6 at week 28, in arm 1 (adalimumab and MTX continued) and arm 2 (adalimumab discontinued, MTX continued). [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The proportions of RA patients in remission, defined as DAS28<2.6, at week 52 in arm 1 (adalimumab and MTX continued) and arm 2 (adalimumab discontinued, MTX continued). [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
- The incidence of flare (defined as DAS28>2.6 or DAS28 increase >1.2 units) at week 4, 8, 12, 20, 28, 36, 44 and 52. [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
- The response rate, defined as return to baseline DAS28+10% after reinstitution of adalimumab (after flare), evaluated at 4, 8 and 12 weeks [ Time Frame: Week 12 after adalimumab reinstitution ] [ Designated as safety issue: No ]
- The physical function, evaluated by HAQ at week 4, 8, 12, 20, 28, 36, 44 , 52 and 104-156. [ Time Frame: Week 104-156 ] [ Designated as safety issue: No ]
- The quality of life, evaluated by EuroQOL EQ-5D, at week 4, 8, 12, 20, 28, 36, 44, 52 and 104-156. [ Time Frame: Week 104-156 ] [ Designated as safety issue: No ]
- The degree of fatigue, evaluated by FACIT, at week 4, 8, 12, 20, 28, 36, 44, 52 and 104-156 [ Time Frame: Week 104-156 ] [ Designated as safety issue: No ]
- The impact of work capacity and activity, evaluated by WIS and WPAI, at week 12, 28, 52 and 104-156 [ Time Frame: Week 104-156 ] [ Designated as safety issue: No ]
- The change in radiological (modified Sharp/van der Heijde) score at week 52 and 104-156. [ Time Frame: Week 104-156 ] [ Designated as safety issue: No ]
| Enrollment: | 33 |
| Study Start Date: | January 2009 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Active comparator. Drug (adalimumab) continued.Study subjects are recruited from patients with rheumatoid arthritis who are in stable remission on adalimumab + methotrexate (MTX) (adalimumab + MTX prescribed in standard care prior to study entry) Continued treatment with adalimumab 40 mg eow plus Methotrexate (MTX; at least 10 mg/wk; orally or subcutaneously) |
Biological: adalimumab
40 mg eow
Other Name: ABT-D2e7, adalimumab, HUMIRA
|
|
Experimental: 2
Study subjects are recruited from patients with rheumatoid arthritis who are in stable remission on adalimumab + methotrexate (MTX) (adalimumab + MTX prescribed in standard care prior to study entry) Discontinuation of adalimumab. MTX continued (at least 10 mg/wk; orally or subcutaneously) |
Biological: adalimumab
40 mg eow
Other Name: ABT-D2e7, adalimumab, HUMIRA
Drug: methotrexate
at least 10 mg/wk; orally or subcutaneously
Other Name: methotrexate
|
Detailed Description:
Primary purpose : Withdrawal of treatment: for details - see above
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age =/>18 years.
- Diagnosis of RA as defined by the 1987-revised ACR-classification and has positive RF test or erosion on X-ray of hands or feet.
- Subject is currently treated with adalimumab and MTX (at least 10 mg/week; orally or subcutaneously).
- Subject is in remission as defined by DAS28<2.6 for at least the 3 past months.
- Concomitant DMARD or oral corticosteroid therapy has been stable for at least 3 months at study entry.
- Female subject is either not of childbearing potential or is practicing a relevant method of birth control (specified in the protocol).
- Subject is judged to be in good general health.
- Subjects must be able and willing to provide written informed consent.
- Subjects must be able and willing to self-administer SC injections or have a qualified person available to administer SC injections.
Exclusion Criteria:
- Treatment with intra-articular or parenteral administration of corticosteroids in the preceding 4 weeks.
- Oral prednisone or prednisone equivalent > 10 mg/day at baseline.
- Joint surgery within the preceding two months.
- History of acute inflammatory joint disease other than RA.
- Treatment with any investigational drug within 30 days or 5 half lives
- whichever is longer prior to study entry.
- Poorly controlled medical condition, which would put the subject at risk by participation in the study.
- History of clinically significant hematologic, renal or liver disease.
- Diagnosis of, or history suggestive of, CNS demyelinating disease.
- History of cancer or lymphoproliferative disease other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma of the cervix.
- History of listeriosis, histoplasmosis, untreated TB, persistent chronic infections, or recent active infections.
- Known immune deficiency or HIV.
- Female subject who is pregnant or breast-feeding or considering becoming pregnant or breast feeding during the study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00808509
Locations
| Sweden | |
| Site Reference ID/Investigator# 22062 | |
| Linkoping, Sweden, 581 85 | |
| Site Reference ID/Investigator# 14022 | |
| Lund, Sweden, 22185 | |
| Site Reference ID/Investigator# 14023 | |
| Malmo, Sweden, 20502 | |
| Site Reference ID/Investigator# 14301 | |
| Oskarstroem, Sweden, 31392 | |
| Site Reference ID/Investigator# 20241 | |
| Skoevde, Sweden, 54185 | |
| Site Reference ID/Investigator# 4918 | |
| Stockholm, Sweden, 171 76 | |
| Site Reference ID/Investigator# 14021 | |
| Stockholm, Sweden, SE-141 86 | |
| Site Reference ID/Investigator# 14302 | |
| Uppsala, Sweden, 75185 | |
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Pharma Consulting Group AB
Investigators
| Study Director: | Mikael Heimburger, MD | AbbVie AB |
More Information
Additional Information:
No publications provided
| Responsible Party: | AbbVie ( AbbVie (prior sponsor, Abbott) ) |
| ClinicalTrials.gov Identifier: | NCT00808509 History of Changes |
| Other Study ID Numbers: | W10-046, 2008-004398-16 |
| Study First Received: | December 12, 2008 |
| Last Updated: | January 2, 2013 |
| Health Authority: | Sweden: Medical Products Agency |
Keywords provided by AbbVie:
|
adalimumab Remission drug discontinuation |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Methotrexate Adalimumab Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 23, 2013