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

Information source: Instituto de Investigacion Biomedica de A Coruna
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psoriatic Arthritis

Intervention: Adalimumab (HUMIRA®) (Drug)

Phase: N/A

Status: Completed

Sponsored by: Dr. FRANCISCO J. BLANCO-GARCIA

Official(s) and/or principal investigator(s):
Francisco J. Blanco-Garcia, MD, PhD, Study Chair, Affiliation: Complejo Hospitalario Universitario A Coruna

Summary

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.

Clinical Details

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

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome:

BASDAI score (Bath Ankylosing Spondylitis Disease Activity Index).

Number of participants with new adverse events.

Secondary outcome:

ASAS 40 score.

ASAS 50 and ASAS 70 score, 5/6.

Evaluation of enthesitis.

Peripheral articulation measured with DAS 28.

Evaluation of extraarticular manifestations.

Measure of laboratory parameters.

Evaluation of quality of life.

Measure of PASI (Psoriasis Area and Severity Index).

Measure of Modified NAPSI (Modified Nail Psoriasis Severity Index).

Measure of BASFI (Bath Ankylosing Spondylitis Functioning Index).

Evaluation of health.

Evaluation of dactylitis.

Measure of inflammatory biomarkers (IL6 and MMP3).

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

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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.

Locations and Contacts

Complejo Hospitalario Universitario A Coruna, A Coruna 15006, Spain

Hospital del Mar, Barcelona 08003, Spain

Hospital Vall d´Hebron, Barcelona 08035, Spain

Hospital Basurto, Bilbao 48013, Spain

Hospital San Pedro de Alcantara, Caceres 10003, Spain

Hospital Universitario Reina Sofia, Cordoba 14004, Spain

Hospital Orense, Orense 32005, Spain

Hospital Pontevedra, Pontevedra 36001, Spain

Hospital de Salamanca, Salamanca 37007, Spain

Hospital Donostia, San Sebastian 20014, Spain

Hospital Virgen de la Macarena, Sevilla 41007, Spain

Hospital Arquitecto Marcide-Novoa Santos, Ferrol, A Coruna 15405, Spain

Hospital de Elche, Elche, Alicante 03203, Spain

Hospital Comarcal Villajoyosa, Villajoyosa, Alicante 03570, Spain

Hospital Central de Asturias, Oviedo, Asturias 33006, Spain

Hospital Monte Naranco, Oviedo, Asturias 33012, Spain

Hospital Bellvitge, L´Hospitalet de Llobregat, Barcelona 08907, Spain

Hospital Parc Tauli, Sabadell, Barcelona 08208, Spain

Hospital General de Jerez, Jerez de la Frontera, Cadiz 11407, Spain

Hospital Doctor Negrin, Las Palmas, Gran Canaria 35010, Spain

Hospital Insular de Las Palmas, Las Palmas, Gran Canaria 35016, Spain

Hospital Meixoeiro, Vigo, Pontevedra 36214, Spain

Additional Information

Starting date: March 2010
Last updated: September 22, 2014

Page last updated: August 23, 2015

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