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Ankylosing SpondylitisPhase 2/3NCT00235105

D2E7-Early AS

A Phase 2/3 study testing Adalimumab 40 mg sc every other week in people with Ankylosing Spondylitis, run by Charite University, Berlin, Germany at 2 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Reduction of signs and symptoms in patients with moderate to severely early axial spondyloarthritis (without radiological sacroiliitis) who have had an inadequate response to or do not tolerate NSAID therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ankylosing Spondylitis
What is being tested?
Adalimumab 40 mg sc every other week
How many people
46 participants
Where
2 sitesGermany
Study dates
Mar 2005to Jun 2007
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Charité Campus Benjamin Franklin, Rheumatology

    Berlin, 12200

  • Rheumazentrum Ruhrgebiet

    Herne, 44625

Other trials in Germany

About this study

Official title: Adalimumab in Early Axial Spondyloarthritis (Without Radiological Sacroiliitis): Placebo Controlled Phase Over 3 Months Followed by a 9 Months Open Extension Phase

Reduction of signs and symptoms in patients with moderate to severely early axial spondyloarthritis (without radiological sacroiliitis) who have had an inadequate response to or do not tolerate NSAID therapy.

Study Objectives:Efficacy -To assess whether patients with moderate to severely active early axial spondyloarthritis (without radiological sacroiliitis) will show response when adalimumab is added to the pre-existing or in case of intolerance to NSAID therapy. Response will be measured at week 12 by change of efficacy parameters compared to baseline.Safety - To demonstrate the safety of adalimumab in study patients with moderate to severely active early axial spondyloarthritis (without radiological sacroiliitis) in patients who have had an inadequate response to or do not tolerate NSAID therapy.

Read the detailed description

The study is a two center 12-week double-blind, placebo-controlled trial of adalimumab in patients with moderate to severely active axial spondyloarthritis (without radiological sacroiliitis) who have had an inadequate response to who are or intolerant to NSAID therapy. Patients may have been treated in the past with concomitant DMARDs. For these patients 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. Patients who have been treated previously with approved biologics are allowed to enter the study if they failed due to lack of efficacy and/or intolerance. The placebo-controlled treatment period of 12 weeks will be followed by an open-label maintenance therapy up to Week 52. Following screening and baseline evaluations, patients will be assessed at Weeks 2, 4, 8, and 12. During the maintenance therapy visits will be performed at Weeks 16, 20 and every eight weeks thereafter.Efficacy and safety measurements will be recorded throughout the entire 52 weeks study.Non-responders (fail to reach ASAS 40) at and after week 12 of open label therapy (at week 24), will be eligible for adalimumab dose escalation to 40 mg weekly.The study will be followed by a 24 weeks follow up phase. During this period the patients will be assessed every eight weeks.

Being tested
Adalimumab 40 mg sc every other week
Keywords
early ankylosing spondylitis, spondyloarthritis, trial, adalimumab
Medical subject headings
Spondylitis, Ankylosing, Spondylarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adalimumab 40 mg sc every other weekDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ASAS 40 at week 12

Secondary outcomes (12)

  1. ASAS 20, 70·

  2. BASDAI 20, 50, 70

  3. BASFI (absolute change from Baseline)

  4. Mobility examinations: BASMI, Chest Wall Expansion

  5. DC-ART20 (5 out of 6)

  6. CRP, ESR

  7. Quality of Life: SF-36

  8. Numeric Rating Scale (NRS) - physicians global, patients global, general pain, nocturnal pain

  9. Enthesitis index (Maastricht scale)

  10. swollen joint count

  11. EQ-5D

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2005 (estimated)
  2. Study startMar 2005
  3. Study completionJun 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Enrolment
46 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00235105
Sponsor's protocol ID
A01
Status last verified
Oct 2005
First submitted
6 Oct 2005
Last updated
9 Dec 2005
Results posted
No

Publications

  • Weiss A, Song IH, Haibel H, Listing J, Sieper J. Good correlation between changes in objective and subjective signs of inflammation in patients with short- but not long duration of axial spondyloarthritis treated with tumor necrosis factor-blockers. Arthritis Res Ther. 2014 Jan 30;16(1):R35. doi: 10.1186/ar4464.

    PubMed 24476416

  • Haibel H, Heldmann F, Braun J, Listing J, Kupper H, Sieper J. Long-term efficacy of adalimumab after drug withdrawal and retreatment in patients with active non-radiographically evident axial spondyloarthritis who experience a flare. Arthritis Rheum. 2013 Aug;65(8):2211-3. doi: 10.1002/art.38014. No abstract available.

    PubMed 23686466

  • Haibel H, Rudwaleit M, Listing J, Heldmann F, Wong RL, Kupper H, Braun J, Sieper J. Efficacy of adalimumab in the treatment of axial spondylarthritis without radiographically defined sacroiliitis: results of a twelve-week randomized, double-blind, placebo-controlled trial followed by an open-label extension up to week fifty-two. Arthritis Rheum. 2008 Jul;58(7):1981-91. doi: 10.1002/art.23606.

    PubMed 18576337

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Adalimumab 40 mg sc every other week in people with Ankylosing Spondylitis, run by Charite University, Berlin, Germany at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ASAS 40 at week 12. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00235105, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2005; AzTrials last refreshed its copy on 29 Oct 2026.

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