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Spondylitis, AnkylosingPhase 3CANDLENCT00202865

Evaluation of Low Dose Infliximab in Ankylosing Spondylitis (Study P04352)

A Phase 3 study testing infliximab in people with Spondylitis, Ankylosing, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized, double-blind, multi-center, placebo-controlled study with two parallel treatment groups (placebo and infliximab) in subjects with ankylosing spondylitis (AS) to evaluate the efficacy of infliximab 3 mg/kg. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spondylitis, Ankylosing
What is being tested?
infliximab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
76 participants
Where
No sites listed yet
Study dates
1 May 2005to 1 May 2007
Phase
Phase 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

  • Are men or women >=18 years of age at Screening.
  • Female subjects of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active during the study) must be using an acceptable method of birth control (eg, hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (eg, hysterectomy or tubal ligation), and must continue such precautions for 6 months after receiving the last study agent infusion, and have a negative serum pregnancy test prior to enrollment. Additionally, male subjects who are sexually active, with women of childbearing potential, should ensure that they or their partners are using adequate contraception
  • Have had a diagnosis of AS according to the modified 1984 New York criteria, prior to Screening.
  • Have active disease, as evidenced by a BASDAI score of >=4 at Baseline and at Screening
  • Screening tests must meet the following criteria:
  • Hemoglobin: >=9.0 g/dL (5.6 mmol/L) for men and >=8.5 g/dL (5.3 mmol/L) for women
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  • Serum transaminase levels must be within 3 times the ULN
  • Serum creatinine <=1.4 mg/dL (107umol/L).
  • Are capable of reading and understanding subject assessment forms and providing written informed consent.
  • Have had a documented negative reaction to a PPD skin test (PPD induration < 5 mm) performed within 1 month prior to the first study infusion. If PPD negative, chest x-ray still required.
  • Subjects must understand English or French.

Who cannot join

  • Have had a serious infection (eg, sepsis, hepatitis, abscesses, pneumonia, or pyelonephritis), have been hospitalized for an infection, or have been treated with intravenous (IV) antibiotics for an infection within 8 weeks prior to randomization. Less serious infections (eg, acute upper respiratory tract infection, or simple urinary tract infection) need not be considered exclusions at the discretion of the investigator.
  • Have ever had a chronic or recurrent infectious disease including, but not limited to, chronic renal infection, chronic chest infection (eg, bronchiectasis), sinusitis, recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), open, draining, or infected skin wound, or ulcer.
  • Have ever had opportunistic infections (eg, herpes zoster (shingles), cytomegalovirus, pneumocystis carinii, aspergillosis, histoplasmosis)
  • Have had documented an atypical mycobacteria infection.
  • Have had active TB or recent close contact with an individual with active TB or ever had evidence of latent TB.
  • Have a chest radiograph (PA and lateral) that displays granulomas or apical fibronodular disease suggestive of previous TB as determined by the investigator.
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  • Have documented Hepatitis B (surface antigen positive).
  • Have documented HIV.
  • Have a known malignancy or history of malignancy within 5-year period prior to Screening (with the exception of squamous or basal cell carcinoma of the skin that has been completely excised without evidence of recurrence). Have a history of lymphoproliferative disease including lymphoma, have multiple sclerosis, or other central demyelinating disorder, or have congestive heart failure.
  • Have a serious concomitant illness, other than the ones mentioned above, that might interfere with participation in the trial.
  • Have a known allergy to murine proteins or other chimeric proteins.
  • Have ever received any previous treatment with infliximab, etanercept or other anti-TNF agents prior to first study infusion.
  • Are pregnant, nursing, or planning pregnancy (both men and women) during the trial or within the 6-month period thereafter.
  • Have a contraindication to any study protocol component.
  • Subjects who have a contraindication to the MRI component of the study can be enrolled, however, they will be exempt from all MRI examinations.
  • Subjects with unstable doses of NSAIDS, DMARDs, analgesics or corticosteroids at Screening who will continue to receive these medications during the study.
  • Subjects who are receiving >10 mg of prednisone (or equivalent) daily.
  • Have a documented history of fibromyalgia confirmed by an appropriate physician specialist (ie, rheumatologist).
  • Have had a documented history of total ankylosis.

About this study

Official title: CANaDian Evaluation of Low DosE Infliximab in Ankylosing Spondylitis

This is a randomized, double-blind, multi-center, placebo-controlled study with two parallel treatment groups (placebo and infliximab) in subjects with ankylosing spondylitis (AS) to evaluate the efficacy of infliximab 3 mg/kg.

Being tested
infliximab, Placebo
Medical subject headings
Spondylitis, Ankylosing

What participants receive

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

  • infliximabBiological

    Also called Remicade, SCH 215596

    Infliximab 3 mg/kg infusions at Weeks 0, 2, and 6 and every 8 weeks thereafter. Subjects who lose response according to a pre-specified criteria at weeks 22 or 38 visit will increase the dose of infliximab to 5 mg/kg (rounded up to the nearest vial).

  • PlaceboBiological

    Placebo infusions at Weeks 0, 2, and 6. Subjects will be evaluated at Week 12 after which they will receive infliximab 3 mg/kg at Weeks 16, 18, and 22 then every 8 weeks. Subjects who lose response according to a pre-specified criteria at weeks 22 or 38 visit will increase the dose of infliximab to 5 mg/kg (rounded up to the nearest vial).

Study groups in NCT00202865
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Biological: infliximab
2Placebo comparatorNot described
Receives: Biological: Placebo

What is being measured

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

  1. The proportion of AS assessment responders ASAS20 (ie, a minimum 20% improvement from Baseline according to the ASAS response criteria) at Week 12.

    Measured: Week 12

Secondary outcomes (14)

  1. Change from Baseline in the magnetic resonance imaging activity score at Week 12.

    Measured: Week 12

  2. Change from Baseline in BASFI at Week 12 and Week 50.

    Measured: Week 12 and Week 50

  3. Change from Baseline in BASDAI at Week 12 and Week 50.

    Measured: Week 12 and Week 50

  4. Change from Baseline in BASGI at Week 12 and Week 50.

    Measured: Week 12 and Week 50

  5. Change from Baseline in spinal mobility (BASMI) at Week 12 and Week 50.

    Measured: Week 12 and Week 50

  6. Change from Baseline in spinal mobility (EDASMI) at Week 12 and Week 50.

    Measured: Week 12 and Week 50

  7. Proportion of subjects achieving an ASAS40 at Week 12 and Week 50.

    Measured: Week 12 and Week 50

  8. Proportion of subjects achieving an ASAS50 at Week 12 and Week 50.

    Measured: Week 12 and Week 50

  9. Proportion of subjects achieving an ASAS70 at Week 12 and Week 50.

    Measured: Week 12 and Week 50

  10. Change from Baseline in the physical component of the SF-36 at Week 12 and Week 50.

    Measured: Week 12 and Week 50

  11. Assess the treatment survival.

    Measured: From baseline to week 50

  12. Quantify the number of subjects requiring dose titration.

    Measured: Week 22 and 38

  13. Assess predictors of response.

    Measured: Week 12 and 50

  14. Assess predictors of toxicity.

    Measured: 50 weeks

Timeline

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

  1. First posted20 Sep 2005 (estimated)
  2. Study start1 May 2005
  3. Primary completion1 May 2007
  4. Study completion1 May 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00202865
Sponsor's protocol ID
P04352
Other IDs
2472
Acronym
CANDLE
Status last verified
Mar 2017
First submitted
16 Sep 2005
Last updated
24 Mar 2017
Results posted
No
Data monitoring committee
No

Publications

  • Inman RD, Maksymowych WP; CANDLE Study Group. A double-blind, placebo-controlled trial of low dose infliximab in ankylosing spondylitis. J Rheumatol. 2010 Jun;37(6):1203-10. doi: 10.3899/jrheum.091042. Epub 2010 Mar 15.

    PubMed 20231198

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing infliximab in people with Spondylitis, Ankylosing, run by Merck Sharp & Dohme LLC.

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 11 inclusion and 19 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: finished, as of the sponsor's last update on 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

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

What does this phase mean?

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The proportion of AS assessment responders ASAS20 (ie, a minimum 20% improvement from Baseline according to the ASAS response criteria) at Week 12. (time frame: 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 NCT00202865, which also lists 1 linked publication.

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 24 Mar 2017.

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