HUmira in Psoriatic Arthritis

NCT01465438 | Completed Phase 4 DMC

• 2 other identifiers: HUPSA HUM 05-0402006-000004-16
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Psoriatic arthritis (PsA) is an inflammatory arthritis associated with psoriasis, which has a estimated prevalence of 0.3 - 1 %. The clinical course varies, but PsA is often a progressive, erosive arthritis causing severe disability and increased mortality. The biologic treatment infliximab and etanercept have recently been introduced for treatment of PsA and psoriasis, and current data indicate a higher efficacy than with previously available therapies. No clinical trials on adalimumab in PsA are yet published (2005), but preliminary data are encouraging. The improved treatment options have increased the need for sensitive methods for diagnosis, monitoring and prognostication of PsA, so that the efficient therapies can be initiated at the optimal time point and monitored optimally. Ultrasonography (US) and magnetic resonance imaging (MRI) and a number of biomarkers are promising, but not yet sufficiently studied, methods for this. The hypothesis is that adalimumab will be an effective treatment option for PsA. Novel imaging- and biomarkers can provide additional information, compared to clinical measures and radiography, concerning activity, destructive progression and prediction of therapeutic response in PsA patients receiving adalimumab. The perspective is a potential improvement in diagnosis, monitoring and prognostication of patients with PsA.

Conditions

Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

• Modified Psoriatic Arthritis Response criteria (PsARC)

  24 weeks

Study Arms (1)

Adalimumab

EXPERIMENTAL

Responders at week 24 continue treatment with adalimumab. Non-responders at week 24 stops treatment with adalimumab.

Drug: Adalimumab

Interventions

Adalimumab DRUG

Adalimumab 40 mg every other week

Also known as: Humira

Adalimumab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject Population: patients with active PsA, fulfilling the following major criteria:
• Diagnosis of PsA according to Moll and Wright criteria (Moll and Wright,
• Clinical active disease, defined as \>2 (of 76) swollen joints and \> 2 (of 78) tender joints
• Involvement of the hands (Clinical swelling of 1 or more finger joint and/or 1 or more 1 sausage finger)
• Clinical indication for anti-TNF alpha therapy, according to treating physician
• Among other issues: Age \>18 years; adequate birth control; no contraindications for anti-TNF alpha-therapy, no previous anti-TNF alpha-therapy, no other significant dermatological disorders than psoriasis.

Sponsors & Collaborators

• Glostrup University Hospital, Copenhagen: lead
• University Hospital, Gentofte, Copenhagen: collaborator
• Copenhagen University Hospital at Herlev: collaborator
• Copenhagen University Hospital, Hvidovre: collaborator

Study Sites (1)

Copenhagen University Hospital, Glostrup

Glostrup Municipality, Copenhagen, 2600, Denmark

Location

Related Publications (1)

• Poggenborg RP, Wiell C, Boyesen P, Boonen A, Bird P, Pedersen SJ, Sorensen IJ, Madsen OR, Slot O, Moller JM, Hasselquist M, Kubassova O, Ostergaard M. No overall damage progression despite persistent inflammation in adalimumab-treated psoriatic arthritis patients: results from an investigator-initiated 48-week comparative magnetic resonance imaging, computed tomography and radiography trial. Rheumatology (Oxford). 2014 Apr;53(4):746-56. doi: 10.1093/rheumatology/ket426. Epub 2013 Dec 24.

  PMID: 24369412 DERIVED

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Charlotte Wiell, MD, PhD

  University Hospital, Gentofte, Copenhagen

  STUDY CHAIR

• Inge Juul Sørensen, MD, PhD

  Copenhagen University Hospital, Hvidovre

  PRINCIPAL INVESTIGATOR

• Michael Sejer Hansen, MD, PhD

  Copenhagen University Hospital at Herlev

  PRINCIPAL INVESTIGATOR

• Ole Rintek Madsen, MD, PhD

  University Hospital, Gentofte, Copenhagen

  PRINCIPAL INVESTIGATOR

• Ole Slot, MD

  Glostrup University Hospital, Copenhagen

  PRINCIPAL INVESTIGATOR

• Susanne J Pedersen, MD

  Gentofte University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 16, 2011
• First Posted: November 4, 2011
• Study Start: November 1, 2006
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: November 4, 2011

Record last verified: 2011-02

Locations

DK (1)