D2E7-Early AS

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00235105
• Date of registration: 06/10/2005
• Prospective Registration: No
• Primary sponsor: Charite University, Berlin, Germany
• Public title: D2E7-Early AS
• Scientific title: Adalimumab in Early Axial Spondyloarthritis (Without Radiological Sacroiliitis): Placebo Controlled Phase Over 3 Months Followed by a 9 Months Open Extension Phase
• Date of first enrolment: March 2005
• Target sample size: 46
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00235105
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 2/Phase 3

Countries of recruitment

Germany

Contacts

• Name: Joachim Sieper, Prof.
• Affiliation: Charité Campus Benjamin Franklin, Rheumatology

Key inclusion & exclusion criteria

Inclusion Criteria:

Patients 18 years of age or older who have moderate to severely active axial
spondyloarthritis.

Diagnosis made by:Chronic low back pain (duration > 3 months, onset < 50 years of age)plus
3 out of the 6 following criteria (including two of the following three criteria:
inflammatory back pain, positive for HLA-B27 and positive MRI showing acute inflammatory
lesions in spine or ISG)

- Inflammatory back pain1

- Good or very good response to NSAIDs

- One or more of the following extraspinal manifestations: uveitis, peripheral
arthritis, enthesitis

- HLA-B27 positive

- Positive MRI showing acute inflammatory lesions in spine or ISG

- Positive family history for SpA Active disease is defined as a BASDAI score of equal
or more than 4, back pain score (BASDAI question 2) of equal or more than 4 despite
concurrent NSAID therapy, or intolerance to NSAIDs.

Other inclusion criteria include:

If on prednisone, equal or less than 7.5 mg per day; stable for 4 weeks prior to baseline.

An evaluation for latent tuberculosis infection will be performed using a Mendel Mantoux
Test with 10TE (PPD), reading a chest x-ray, which should have been performed within the
last 12 weeks before inclusion, and history of exposure to infected subjects. Patients who
have evidence of latent TB infection should be given prophylaxis in accordance with local
guidelines (Isoniazid 300 mg with adequate substitution of vitamin B6 for 9 months or 600
mg Rifampicine for 6 months). The prophylaxis will start 4 weeks before adalimumab is
administered. After 2 weeks of prophylaxis blood tests (liver enzymes, creatinine and
blood count) will be obtained. Patients with documented prophylaxis in the past need not
to repeat this treatment.

Women of child bearing potential must have a negative pregnancy test at study baseline and
use an adequate method of contraception (including 3 months after study completion).
Sexual active men must use an accepted method of contraception including 3 months after
study completion.

Able to self-administer injectable drug supplies or have a caregiver who will do so.

Able to store injectable test article at 2° to 8° C.

Exclusion Criteria:

Definite ankylosing spondylitis (according to modified New York criteria, sacroiliitis ³
grade 2 bilaterally or grade 3 to 4 unilaterally) History of active tuberculosis (TB),
histoplasmosis or listeriosis. History of positive HIV status. Positive serology for
hepatitis B or C indicating active infection, in case of hepatitis B also if indicating
chronic infection History of malignancy other than carcinoma in situ of the cervix or
adequately treated non-metastatic squamous or basal cell skin carcinoma.

Antibiotic treatment within 3 weeks prior to screening. Treatment with biologicals within
the last 12 weeks If on DMARDs a washout period of at least 4 weeks is necessary. If
Leflunomide was discontinued, it should be stopped at least 3 months or should be washed
out within 4 weeks before study start.

History of uncontrolled diabetes, unstable ischemic heart disease, active inflammatory
bowel disease, active peptic ulcer disease, recent stroke (within 3 months), ongoing
congestive heart failure, and any other condition which, in the opinion of the
investigator, would put the subject at risk by participation in the protocol.

Female subjects who are pregnant or breast-feeding. Previous diagnosis or signs of
demyelinating diseases History of systemic lupus erythematosusReceipt of any live
(attenuated) vaccines within 4 weeks before screening visit Laboratory exclusions are:
hemoglobin level < 8,5 mg/dl, white blood cell count < 3.5 x109/l, platelet count < 125 x
109 /l, creatinine level > 175 µmol/liver enzymes or alkaline phosphatase >2 times the
upper limit of normal.

Participation in trials of other investigational medications within 30 days of entering
the study Clinical examination showing significant abnormalities of clinical relevance
History or current evidence of abuse of ”hard” drugs (e.g. cocaine/heroine) or alcoholism



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Intervention(s)

Drug: Adalimumab 40 mg sc every other week

Primary Outcome(s)

ASAS 40 at week 12

Secondary Outcome(s)

Mobility examinations: BASMI, Chest Wall Expansion

EQ-5D

BASFI (absolute change from Baseline)

ASAS 20, 70·

Numeric Rating Scale (NRS) – physicians global, patients global, general pain, nocturnal pain

BASDAI 20, 50, 70

DC-ART20 (5 out of 6)

Safety Evaluations: Adverse events, vital signs, physical examination results, and clinical laboratory values.

Quality of Life: SF-36

swollen joint count

CRP, ESR

Enthesitis index (Maastricht scale)

Secondary ID(s)

N.A.

A01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Abbott