A 24 Week Open Label Study of the Utility of Adalimumab in Active Axial Forms of Psoriatic Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. FRANCISCO J. BLANCO-GARCIA, Instituto de Investigacion Biomedica de A Coruna
ClinicalTrials.gov Identifier:
NCT00963313
First received: August 20, 2009
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

Based on published data and according to the approved product label for ankylosing spondylitis and psoriatic arthritis, it can be expected that adalimumab 40 mg every 14 days should be effective in psoriatic arthritic patients with axial involvement.


Condition Intervention
Psoriatic Arthritis
Drug: Adalimumab (HUMIRA®)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Instituto de Investigacion Biomedica de A Coruna:

Primary Outcome Measures:
  • BASDAI score (Bath Ankylosing Spondylitis Disease Activity Index). [ Time Frame: 12 WEEKS ] [ Designated as safety issue: No ]
    Proportion of patients that reach a BASDAI 50% at week 12, BASDAI 50% means an improvement from baseline of 50% or an improvement of two units on a 10 unit scale.

  • Number of participants with new adverse events. [ Time Frame: 24 WEEKS ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • ASAS 40 score. [ Time Frame: 24 WEEKS ] [ Designated as safety issue: No ]
  • ASAS 50 and ASAS 70 score, 5/6. [ Time Frame: 12 WEEKS ] [ Designated as safety issue: No ]
  • Evaluation of enthesitis. [ Time Frame: 24 WEEKS ] [ Designated as safety issue: No ]
  • Peripheral articulation measured with DAS 28. [ Time Frame: 24 WEEKS ] [ Designated as safety issue: No ]
  • Evaluation of extraarticular manifestations. [ Time Frame: 24 WEEKS ] [ Designated as safety issue: No ]
  • Measure of laboratory parameters. [ Time Frame: 24 WEEKS ] [ Designated as safety issue: No ]
    Hematology, biochemistry, CRP, ESR, HLA-B27 and rheumatoid factor.

  • Evaluation of quality of life. [ Time Frame: 24 WEEKS ] [ Designated as safety issue: No ]
    SF36

  • Measure of PASI (Psoriasis Area and Severity Index). [ Time Frame: 24 WEEKS ] [ Designated as safety issue: No ]
  • Measure of Modified NAPSI (Modified Nail Psoriasis Severity Index). [ Time Frame: 24 WEEKS ] [ Designated as safety issue: No ]
  • Measure of BASFI (Bath Ankylosing Spondylitis Functioning Index). [ Time Frame: 24 WEEKS ] [ Designated as safety issue: No ]
  • Evaluation of health. [ Time Frame: 24 WEEKS ] [ Designated as safety issue: No ]
    HAQ (Health Assessment Questionarie).

  • Evaluation of dactylitis. [ Time Frame: 24 WEEKS ] [ Designated as safety issue: No ]
  • Measure of inflammatory biomarkers (IL6 and MMP3). [ Time Frame: 24 WEEKS ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: March 2010
Study Completion Date: June 2014
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Adalimumab, injection Drug: Adalimumab (HUMIRA®)
Prefilled syringes containing 40 mg Adalimumab in 0.8 ml injection solution. Study drug will be subcutaneously self-administered every 2 weeks during 24 weeks.

Detailed Description:

A recent review from GRAPPA group evaluates therapies for PsA including peripheral and axPsA. Analysing particularly the results with present biologic therapies it has been proven that outcome data at 24 weeks show excellent results in the treatment of peripheral forms of PsA with either of the three biologics disposable in the market, that is to say infliximab, etanercept and adalimumab.

However when it comes to analyse data on PsA patients with axPsA there are not results at all. The design of clinical trials did not evaluate axial outcomes and therefore there is not a possibility of knowing whether these therapies are useful in axPsA.

This is an open label multicenter study designed to evaluate the effectivity of adalimumab 40 mg every 2 weeks during 24 weeks in patients with active axial PsA despite receiving Methotrexate, Sulfasalazine, Leflunomide or Cyclosporine, plus NSAIDs and no more than 10 mg of corticosteroids.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with active axial forms of psoriatic arthritis

Criteria

Inclusion Criteria:

  • Males and females aged between 18 and 70 years.
  • A negative pregnancy test for women of childbearing potential during the screening period.
  • Subject must be evaluated for active or latent TB (tuberculosis) infection by using a PPD skin test (Mantoux test), Booster test, chest x-ray and detailed review of subjetc´s medical history.
  • Subjects to whom the doctor has decided to prescribe adalimumab, because of fulfilling the requirements for this treatment.
  • Diagnosed with PsA according to CASPAR criteria.
  • Axial disease according to radiological criteria (at least unilateral sacroilitis grade II) and spinal inflammatory symptoms.
  • Disease duration of no less than 24 weeks
  • Patients with peripheral involvement (mixed forms of APs) must have been taking MTX for at least 12 weeks before screening and at stable doses of 10 to 25 mg/week for 8 weeks before screening, or salazopyrine up to 3 mg/daily, or cyclosporin 2mg/kg or leflunomide 20 mg daily in the same conditions as MTX.
  • Patient's doses of NSAIDs and oral corticosteroids (≤ 10 mg/day of prednisone or equivalent) should have been kept stable for 4 weeks before screening.

Exclusion Criteria:

  • Contraindications for treatment with anti-TNF.
  • Prior treatment with other TNF inhibitors or other investigational drugs during the last 30 days (etanercept 4 weeks, infliximab 8 weeks).
  • Uncontrolled diabetes.
  • Uncontrolled high blood pressure.
  • Unstable ischemic heart disease.
  • Congestive heart failure.
  • Severe pulmonary disease.
  • Chronic leg ulcer.
  • History of cancer or malignant lymphoproliferative disease.
  • Positive serology for Hepatitis B indicating active infection or positive serology for Hepatitis C.
  • History of positive HIV status.
  • Persistent, recurrent or severe infections requiring hospitalization or treatment with oral antibiotics within 14 days prior to enrollment.
  • Previous diagnosis or signs highly indicative of central nervous system demyelinating diseases.
  • Active tuberculosis, histoplasmosis or listeriosis.
  • History or presence of confirmed blood dyscrasia.
  • Female subjects who are pregnant or breast-feeding.
  • History of clinically significant drug or alcohol abuse in the last year.
  • Treatment with MTX, salazopyrine, ciclosporin or leflunomide initiated within the last 4 weeks before the screening. Treatment with corticosteroids (>10mg/day or equivalent or modified dose within the previous 4 weeks before screening). And patients where an intraarticular corticoid infiltration has been practised within the last 4 weeks before the screening will be excluded from the study.
  • Treatment with more than one NSAID within the last 4 weeks before the screening.
  • Patients treated with any DMARD different from MTX, cyclosporine, leflunomide and sulfasalazine.
  • Dosage of concomitant MTX, cyclosporine, leflunomide and sulfasalazine must be stable during the study, otherwise it should be properly justified and recorded in the case report form.
  • Patients treated with any analgesic different from acetominophen, NSAIDs, oxycodone, codeine, propoxyphene, tramadol, hydrocodone or combinations of these products or equivalents. The use of potent opioids is not permitted.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00963313

Locations
Spain
Hospital Arquitecto Marcide-Novoa Santos
Ferrol, A Coruna, Spain, 15405
Hospital de Elche
Elche, Alicante, Spain, 03203
Hospital Comarcal Villajoyosa
Villajoyosa, Alicante, Spain, 03570
Hospital Central de Asturias
Oviedo, Asturias, Spain, 33006
Hospital Monte Naranco
Oviedo, Asturias, Spain, 33012
Hospital Bellvitge
L´Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital Parc Tauli
Sabadell, Barcelona, Spain, 08208
Hospital General de Jerez
Jerez de la Frontera, Cadiz, Spain, 11407
Hospital Doctor Negrin
Las Palmas, Gran Canaria, Spain, 35010
Hospital Insular de Las Palmas
Las Palmas, Gran Canaria, Spain, 35016
Hospital Meixoeiro
Vigo, Pontevedra, Spain, 36214
Complejo Hospitalario Universitario A Coruna
A Coruna, Spain, 15006
Hospital Vall d´Hebron
Barcelona, Spain, 08035
Hospital del Mar
Barcelona, Spain, 08003
Hospital Basurto
Bilbao, Spain, 48013
Hospital San Pedro de Alcantara
Caceres, Spain, 10003
Hospital Universitario Reina Sofia
Cordoba, Spain, 14004
Hospital Orense
Orense, Spain, 32005
Hospital Pontevedra
Pontevedra, Spain, 36001
Hospital de Salamanca
Salamanca, Spain, 37007
Hospital Donostia
San Sebastian, Spain, 20014
Hospital Virgen de la Macarena
Sevilla, Spain, 41007
Sponsors and Collaborators
Dr. FRANCISCO J. BLANCO-GARCIA
Investigators
Study Chair: Francisco J. Blanco-Garcia, MD, PhD Complejo Hospitalario Universitario A Coruna
  More Information

No publications provided

Responsible Party: Dr. FRANCISCO J. BLANCO-GARCIA, MD, PhD, Instituto de Investigacion Biomedica de A Coruna
ClinicalTrials.gov Identifier: NCT00963313     History of Changes
Other Study ID Numbers: SUE-ADA-2009-01
Study First Received: August 20, 2009
Last Updated: August 14, 2014
Health Authority: Spain: Ethics Committee

Keywords provided by Instituto de Investigacion Biomedica de A Coruna:
Axial psoriatic arthritis
Adalimumab
Humira
anti-TNF

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 26, 2014