A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Peripheral Spondyloarthritis

Phase 1

Conditions: Peripheral Spondyloarthritis
MedDRA version: 12.1 Level: HLT Classification code 10052775 Term: Spondyloarthropathies

Registration Number: EUCTR2009-014567-39-GR

Lead Sponsor: Abbott GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 165

Inclusion Criteria

1. Subject is = 18 years of age.
2. Subject must have had, as defined by the Investigator, an inadequate response to
= 2 NSAIDs, or are intolerant to or have a contraindication for NSAIDs.
3. Subjects must have current arthritis (asymmetric or predominantly in the lower
limbs) or enthesitis (except for enthesitis only along the spine, sacroiliac joints
and/or chest wall) or dactylitis PLUS:
? At least one of the following SpA features
o Anterior uveitis confirmed by an ophthalmologist (past or present)
o Crohn's disease or ulcerative colitis diagnosed by a physician (past or
present)
o Evidence of preceding infection (acute diarrhea or non-gonococcal
urethritis or cervicitis 1 month before arthritis)
o HLA-B27 positivity
o Sacroiliitis on imaging; based on prior MRI (refer to Section 1.3 for
definition)
OR
? At least two of the following SpA features:
o Arthritis (past or present diagnosis), adequately documented and
identified, or diagnosed by a qualified medical professional
o Enthesitis (any location, past or present diagnosis), adequately
documented and identified, or diagnosed by a qualified medical
professional
o Dactylitis (past or present diagnosis) adequately documented and
identified, or diagnosed by a qualified medical professional
o Inflammatory Back Pain (past or present) (refer to Section 1.3 for
definition)
o Family history for SpA (refer to Section 1.3 for definition)
4. Subjects must have at Screening and Baseline Visit any one of the following:
? = 2 tender joints and = 2 swollen joints, (asymmetric or predominantly in the
lower limbs)
OR
? at least 1 joint with active inflammatory arthritis, not associated with
dactylitis, plus
? = 2 enthesitis sites (except for enthesitis only along the spine, sacroiliac
joints and/or chest wall)
OR
? = 2 digits with dactylitis;
5. Subject must have had onset of peripheral SpA symptoms = 3 months prior to the
Baseline Visit.
6. Subjects must have baseline disease activity as defined by Patient Global
Assessment of Disease Activity VAS = 40 mm and Patient Global Assessment of
Pain VAS = 40 mm at Screening and Baseline Visits.
7. In subjects with concurrent axial SpA symptoms, the peripheral SpA symptoms
must be the predominant symptoms at study entry based on the Investigator's
clinical judgment.
8. If female, subject is either not of childbearing potential, defined as postmenopausal
for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral
oophorectomy or hysterectomy) or is of childbearing potential and is practicing an
approved method of birth control throughout the study and for 150 days after last
dose of study drug.
Examples of approved methods of birth con

Exclusion Criteria

1. History of a diagnosis of psoriasis or psoriatic arthritis.
2. Subject fulfilling a diagnosis of ankylosing spondylitis (as defined by the modified
New York criteria; Appendix C) at or prior to the Screening Visit.
3. Presence of back pain = 20 mm on a Total Back Pain VAS at Screening or
Baseline.
4. Subject with extra-articular manifestation (e.g., inflammatory bowel disease,
uveitis, etc.) that is not clinically stable for at least 28 days prior to baseline.
5. Medical history of inflammatory arthritis of a different etiology other than
peripheral spondyloarthritis (e.g., rheumatoid arthritis, systemic lupus
erythematosus, gout, or any arthritis with onset prior to age 16 years such as JIA).
6. Prior exposure to any biologic therapy with a potential therapeutic impact on SpA,
including anti-TNF therapy.
7. Subject has received cyclosporine or other second line anti-rheumatic therapy
(except MTX, SSZ, azathioprine or hydroxychloroquine) within 28 days prior to
the Baseline Visit.
8. If entering the study on concomitant DMARDs at Screening/Baseline, subject not
on stable dose of MTX (= 25 mg per week) and/or SSZ (= 3 g per day) and/or
hydroxychloroquine (= 400 mg per day) for 28 days prior to the Baseline Visit.
9. If entering the study on concomitant azathioprine, subject not on stable dose
(= 150 mg/day) for 28 days prior to the Baseline Visit or on azathioprine and
another concomitant immunosuppressive drug at study entry.
10. If entering the study on concomitant NSAIDs and/or analgesics, subject on opioid
analgesics (other than tramadol) or subject not on stable doses for 14 days prior to
baseline.
11. Treatment with intra-articular joint injection(s) of corticosteroids in the preceding
28 days prior to the Baseline Visit.
12. Treatment with any investigational drug of chemical or biologic nature within a
minimum of 30 days or 5 half lives (whichever is longer) of the drug prior to the
Baseline Visit.
13. Infection(s) requiring treatment with intravenous (IV) anti-infectives within
30 days prior to the Baseline Visit or oral anti-infectives within 14 days prior to
the Baseline Visit.
14. Known hypersensitivity to the excipients of adalimumab as stated in the label
(Table 3).
15. History of CNS demyelinating disease or neurologic symptoms suggestive of CNS
demyelinating disease;
16. History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection,
human immunodeficiency virus (HIV) infection, immunodeficiency syndrome,
chronic recurring infections or active TB.
17. History of moderate to severe congestive heart failure (NYHA class III or IV),
recent cerebrovascular accident and any other condition which, in the opinion of
the Investigator, would put the subject at risk by participation in the protocol.
18. Evidence of dysplasia or history o

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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